import alert 99-32 - pharmacompass.com · 2017. 12. 26. · import alert 99-32 ( n o t e : t h i s...

Import Alert 99-32

(Note: This import alert represents the Agency's current guidance to FDA fieldpersonnel regarding the manufacturer(s) and/or products(s) at issue. It does notcreate or confer any rights for or on any person, and does not operate to bind FDA orthe public).Import Alert # 99-32Published Date: 12/08/2017Type: DWPE

Import Alert Name:"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMSREFUSING FDA FOREIGN ESTABLISHMENT INSPECTION"

Reason for Alert:NOTE: Revision to this Import Alert dated July 21, 2014 revises the Reason for Alertand Charge sections to change the word "agency" to "agent". Changes are bracketed

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by three asterisks (***).

As part of FDA's activities intended to protect the health and safety of US consumers,FDA often conducts establishment inspections of foreign manufacturers who produceFDA-regulated articles intended for sale in the US. As part of FDA's foreign inspection process, the Agency may contact the foreignmanufacturer and schedule the establishment inspection; however, there is no suchrequirement to do so. Access to these facilities is a critical aspect of protecting thehealth and safety of US citizens from unsafe products of foreign origin. The refusal to permit inspection of a foreign facility or provide reasonable access toFDA's inspectional personnel, combined with other evidence, provides anappearance that the firm's products are manufactured, processed, or packed underinsanitary conditions.

The Red List identifies firm(s) that have offered FDA-regulated articles for import intothe United States and yet refused to allow the completion of an FDA inspection oftheir foreign establishment(s) for the purpose of determining establishment conditionsand compliance with applicable laws and regulations, for example compliance withFDA's Low-Acid Canned Food regulation, 21 C.F.R. Part 113. On the basis of arefusal from the firm(s), listed on the Red List, combined with other evidence, itappears that their articles were manufactured, processed, or packed under insanitaryconditions for purposes of section 801(a)(1) of the act; therefore such articles aresubject to refusal of admission into the US.

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011.Section 306 of FSMA, codified in section 807 of the FD&C Act (21 U.S.C. 384c(b)),provides FDA with the authority to refuse admission of food into the United States if itis from a foreign factory, warehouse, or other establishment of which the owner,operator, or agent in charge, or the government of the foreign country, refuses topermit entry of United States inspectors or other individuals duly designated by theSecretary, upon request, to inspect such factory, warehouse, or other establishment.For the purposes of this charge, such an owner, operator, or agent in charge shall beconsidered to have refused an inspection if such owner, operator, or agent in chargedoes not permit an inspection of a factory, warehouse, or other establishment duringthe 24-hour period after such request is submitted, or after such time period, asagreed upon by FDA and the foreign factory, warehouse, or other establishment.

Foreign factories, warehouses, or other establishments who refuse to permit entry ofUnited States inspectors or other individuals, duly designated by the Secretary, toinspect their factories, warehouses, or other establishments will be listed on the RedList of this Import Alert, food products from those facilities are subject to refusal ofadmission as set forth in section 807 of the FD&C Act.

The Food and Drug Administration Safety and Innovation Act (FDASIA) was signedinto law on July 9, 2012. Section 707 of FDASIA added a new section 501(j) to theFD&C Act, making a drug adulterated if it has been manufactured, processed,packed, or held in any factory, warehouse, or establishment and the owner, operator,or ***agent*** of such factory, warehouse, or establishment delays, denies, or limitsan inspection, or refuses to permit entry or inspection. Articles of drug that have beenmanufactured, processed, packed, or held in any factory, warehouse, orestablishment of which the owner, operator, or ***agent*** has delayed, denied, orlimited an inspection, or refused to permit entry or inspection, appear to beadulterated and are subject to refusal under section 801(a)(3) of the FD&C Act.

Guidance:Districts may detain without physical examination all products from the firm(s)identified on the Red List to this import alert.

NOTE: If an article is subject to Refusal of Admission per Section 801(a)(1) or 807(b)of the FD&C Act, FDA considers submission of analytical results to be insufficient toovercome the appearance of the product having been prepared, packed, or heldunder insanitary conditions. In addition, the appearance of a violation per Section801(a)(1) of the FD&C Act precludes reconditioning under Section 801(b) of theFD&C Act.

Products imported from the firm(s) listed on the Red List to this import alert shouldremain subject to detention without physical examination until an FDA inspection iscompleted. Firms may provide copies of inspection reports for inspections performedby third parties only to assist FDA in prioritizing inspection requests.

A manufacturer wishing to schedule an FDA inspection or to provide a copy of aninspection report conducted by a third party, should do so by submitting a request ordocumentation to the following address:

Food and Drug Administration Division of Import Operations 12420 Parklawn Drive ELEM 3109 Rockville, MD 20857 Or via email: [email protected]

Product Description:PRODUCT:

See Red List

PRODUCT CODE:

See Red List

PROBLEM:

Inspection Refusal

Charge:(If the article is from a firm that has refused establishment inspection which, combinedwith other evidence, provides an appearance that the article has been manufactured,processed, or packed under insanitary conditions): "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that thearticle appears to have been manufactured, processed, or packed under insanitaryconditions."

OASIS CHARGE CODE: REFUSE EI

(If the article is a drug that has been manufactured, processed, packed, or held in anyfactory, warehouse, or establishment and the owner, operator, or ***agent*** of suchfactory, warehouse, or establishment delays, denies, or limits an inspection, orrefuses to permit entry or inspection): "The article of drug is subject to refusal of admission pursuant to Section 801(a)(3) inthat the article of drug appears to be adulterated under section 501(j) of the FD&CAct."

OASIS CHARGE CODE: DRG REF EI

(If the article is food from a foreign establishment that refuses to permit entry ofUnited States inspectors or other individuals, duly designated by the Secretary, toinspect their facilities): "The food is subject to refusal of admission pursuant to Section 807 in that the foreignfactory, warehouse, or other establishment of which the owner, operator, or agent incharge, or the government of the foreign country, refuses to permit entry of UnitedStates inspectors or other individuals duly designated by the Secretary, upon request,to inspect such factory, warehouse, or other establishment."

OASIS CHARGE CODE: 807REFUSAL

Maher Industries Ltd. Date Published : 12/16/2014

Baoying County Fukang Medical Appliance Co., Ltd.Date Published : 09/20/2016

55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 12/16/201460 - - - -- Human and Animal Drugs Date Published: 12/16/201461 - - - -- Human and Animal Drugs Date Published: 12/16/201462 - - - -- Human and Animal Drugs Date Published: 12/16/201463 - - - -- Human and Animal Drugs Date Published: 12/16/201464 - - - -- Human and Animal Drugs Date Published: 12/16/201465 - - - -- Human and Animal Drugs Date Published: 12/16/201466 - - - -- Human and Animal Drugs Date Published: 12/16/2014

55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 09/20/2016

56 - - - -- Antibiotics (Human/Animal) Date Published: 09/20/2016

60 - - - -- Human and Animal Drugs Date Published: 09/20/2016







List of firms and their products subject to Detention without PhysicalExamination (DWPE) under this Import Alert (a.k.a. Red List)

CANADA

451 Smith Street , Arthur, Ontario CANADA

CHINA

Trade of , Su Zhongbeilu; Baoyingxian , Yangzhou, Jiangsu CHINA

Notes:All Drug and Drug Products









Beijing Shunxin Meihua Bio-technical Co., Ltd. Date Published : 07/22/2014

Beijing Taiyang Pharmaceutical Industry Co Ltd Date Published : 04/28/2016

Beyond Technology Corporation Nanchang Date Published : 04/19/2016



















No 7 Fuqiandongjie , Shunyi District , Shunyiqu, Beijingshi CHINA

Notes:All drug products; Firm refused FDA inspection









NO 1 Shuangqiao (E) Road , Chaoyang, Beijing CHINA










NO 162 Kejidadao , Qingshanhu , Nanchang, Jiangxi CHINA

Chaozhou Chaoan Sauce Stuff Provinsion Fty Date Published : 11/20/2014

53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride(Oral Hygiene Products)

Date Published: 04/19/2016

53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 04/19/2016










02 - - - -- Whole Grain/Milled Grain Prod/Starch Date Published: 11/20/2014

03 - - - -- Bakery Prod/Dough/Mix/Icing Date Published: 11/20/2014

Desc:All Drug and Drug ProductsNotes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, onlyproducts found to be drug products are subject to DWPE under this listing.

Desc:All Drug and Drug ProductsNotes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, onlyproducts found to be drug products are subject to DWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, onlyproducts found to be drug products are subject to DWPE under this listing.









Caitang,chaoan County , Chaozhou, Yandongsheng CHINA

Notes:All Food Products;Problem(s): Inspection Refusal

04 - - - -- Macaroni/Noodle Prod Date Published: 11/20/2014

05 - - - -- Cereal Prep/Breakfast Food Date Published: 11/20/2014

07 - - - -- Snack Food Item Date Published: 11/20/2014

09 - - - -- Milk/Butter/Dried Milk Prod Date Published: 11/20/2014

12 - - - -- Cheese/Cheese Prod Date Published: 11/20/2014

13 - - - -- Ice Cream Prod Date Published: 11/20/2014

14 - - - -- Filled Milk/Imit Milk Prod Date Published: 11/20/2014

15 - - - -- Egg/Egg Prod Date Published: 11/20/2014

16 - - - -- Fishery/Seafood Prod Date Published: 11/20/2014

17 - - - -- Meat, Meat Products and Poultry Date Published: 11/20/2014

18 - - - -- Vegetable Protein Prod Date Published: 11/20/2014

20 - - - -- Fruit/Fruit Prod Date Published: 11/20/2014



23 - - - -- Nuts/Edible Seed Date Published: 11/20/2014

24 - - - -- Vegetables/Vegetable Products Date Published: 11/20/2014


26 - - - -- Vegetable Oils Date Published: 11/20/2014

27 - - - -- Dressing/Condiment Date Published: 11/20/2014

28 - - - -- Spices, Flavors And Salts Date Published: 11/20/2014

29 - - - -- Soft Drink/Water Date Published: 11/20/2014























30 - - - -- Beverage Bases/Conc/Nectar Date Published: 11/20/2014

31 - - - -- Coffee/Tea Date Published: 11/20/2014

32 - - - -- Alcoholic Beverage Date Published: 11/20/2014

33 - - - -- Candy W/O Choc/Special/Chew Gum Date Published: 11/20/2014

34 - - - -- Choc/Cocoa Prod Date Published: 11/20/2014

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 11/20/2014

36 - - - -- Food Sweeteners (Nutritive) Date Published: 11/20/2014

37 - - - -- Mult Food Dinner/Grav/Sauce/Special Date Published: 11/20/2014

38 - - - -- Soup Date Published: 11/20/2014

39 - - - -- Prep Salad Prod Date Published: 11/20/2014

40 A - - -- Baked Goods (Baby) Date Published: 11/20/2014

40 B - - -- Cereal (Baby) Date Published: 11/20/2014

40 D - - -- Veg (Baby) Date Published: 11/20/2014

40 E - - -- Fruit/Juice/Drink (Baby) Date Published: 11/20/2014

40 F - - -- Meat Prod/Comb Meat Dinner (Baby) Date Published: 11/20/2014

40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 11/20/2014

40 H - - -- High Meat Dinner/Cheese Food (Baby) Date Published: 11/20/2014

40 I - - -- Fish-Seafood Prod (Baby) Date Published: 11/20/2014

40 J - - -- Egg Prod (Baby) Date Published: 11/20/2014

40 K - - -- Pudding/Custard (Baby) Date Published: 11/20/2014

40 L - - -- Soups/Soup Mix (Baby) Date Published: 11/20/2014

40 Q - - -- Pasta and Noodle Combination Dinners Without Meat






















Gauke Healthcare Co., Ltd. Date Published : 03/28/2017

Guangxi Jisheng Foods Inc Date Published : 10/04/2013

Date Published: 11/20/2014

40 X - - -- Market Basket Sampling Date Published: 11/20/2014

40 Y - - -- Baby Food N.E.C. Date Published: 11/20/2014

41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 11/20/2014

52 B - - 06 Corn Husks (Food Related) Date Published: 11/20/2014

52 B - - 07 Snail Shells (Food Related) Date Published: 11/20/2014

52 B - - 08 Sausage Casings, Artificial (Food Related) Date Published: 11/20/2014

52 B - - 12 Bird's Nest Date Published: 11/20/2014

52 D - - -- Live Animals Date Published: 11/20/2014




















Chengnan Industrial Park , Tuanfang Dadao; Tuanfengxian , Huanggang, HubeiCHINA










5 Latitude Four Road , Liujing Industrial Park, Liujing , Hengxian County, GuangxiCHINA

03 - - - -- Bakery Prod/Dough/Mix/Icing Date Published: 10/04/201304 - - - -- Macaroni/Noodle Prod Date Published: 10/04/201305 - - - -- Cereal Prep/Breakfast Food Date Published: 10/04/201307 - - - -- Snack Food Item Date Published: 10/04/201309 - - - -- Milk/Butter/Dried Milk Prod Date Published: 10/04/201312 - - - -- Cheese/Cheese Prod Date Published: 10/04/201313 - - - -- Ice Cream Prod Date Published: 10/04/201314 - - - -- Filled Milk/Imit Milk Prod Date Published: 10/04/201315 - - - -- Egg/Egg Prod Date Published: 10/04/201316 - - - -- Fishery/Seafood Prod Date Published: 10/04/201317 - - - -- Meat, Meat Products and Poultry Date Published: 10/04/201318 - - - -- Vegetable Protein Prod Date Published: 10/04/201320 - - - -- Fruit/Fruit Prod Date Published: 10/04/201321 - - - -- Fruit/Fruit Prod Date Published: 10/04/201322 - - - -- Fruit/Fruit Prod Date Published: 10/04/201323 - - - -- Nuts/Edible Seed Date Published: 10/04/201324 - - - -- Vegetables/Vegetable Products Date Published: 10/04/201325 - - - -- Vegetables/Vegetable Products Date Published: 10/04/201326 - - - -- Vegetable Oils Date Published: 10/04/201327 - - - -- Dressing/Condiment Date Published: 10/04/201328 - - - -- Spices, Flavors And Salts Date Published: 10/04/201329 - - - -- Soft Drink/Water Date Published: 10/04/201330 - - - -- Beverage Bases/Conc/Nectar Date Published: 10/04/201331 - - - -- Coffee/Tea Date Published: 10/04/201332 - - - -- Alcoholic Beverage Date Published: 10/04/201333 - - - -- Candy W/O Choc/Special/Chew Gum Date Published: 10/04/201334 - - - -- Choc/Cocoa Prod Date Published: 10/04/201335 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 10/04/201336 - - - -- Food Sweeteners (Nutritive) Date Published: 10/04/201337 - - - -- Mult Food Dinner/Grav/Sauce/Special Date Published: 10/04/201338 - - - -- Soup Date Published: 10/04/201339 - - - -- Prep Salad Prod Date Published: 10/04/201340 A - - -- Baked Goods (Baby) Date Published: 10/04/201340 B - - -- Cereal (Baby) Date Published: 10/04/201340 D - - -- Veg (Baby) Date Published: 10/04/201340 E - - -- Fruit/Juice/Drink (Baby) Date Published: 10/04/201340 F - - -- Meat Prod/Comb Meat Dinner (Baby) Date Published: 10/04/201340 G - - -- Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 10/04/201340 H - - -- High Meat Dinner/Cheese Food (Baby) Date Published: 10/04/201340 I - - -- Fish-Seafood Prod (Baby) Date Published: 10/04/201340 J - - -- Egg Prod (Baby) Date Published: 10/04/201340 K - - -- Pudding/Custard (Baby) Date Published: 10/04/201340 L - - -- Soups/Soup Mix (Baby) Date Published: 10/04/2013

Guangzhou Baiyunshan Guanghua Pharmacy Co. Ltd.Date Published : 08/22/2016

Hangzhou Hetd Industry Co., Ltd. Date Published : 05/01/2013

40 Q - - -- Pasta and Noodle Combination Dinners Without Meat Date Published: 10/04/2013

40 X - - -- Market Basket Sampling Date Published: 10/04/201340 Y - - -- Baby Food N.E.C. Date Published: 10/04/201341 - - - -- Dietary Conv Food/Meal Replacements Date Published: 10/04/201352 B - - 06 Corn Husks (Food Related) Date Published: 10/04/201352 B - - 07 Snail Shells (Food Related) Date Published: 10/04/201352 B - - 08 Sausage Casings, Artificial (Food Related) Date Published: 10/04/201352 B - - 12 Bird's Nest Date Published: 10/04/201352 D - - -- Live Animals Date Published: 10/04/2013

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal) Date Published: 08/22/2016











NO. 1 16 Nanshi Road , Haizhu District , Guangzhou, Yandongsheng CHINA

Notes:All Drug, Drug Products, and Dietary Supplements










Xiyuan Yi Road , 8 Sandun Jie , Hangzhou, Zhejiang CHINA

Hubei Merryclin Pharmaceutical Co., Ltd. Date Published : 09/28/2017

Jiangsu Longliqi Bioscience Co Ltd. Date Published : 10/20/2016

Jiangsu Terra Medical Technology Co. Ltd. Date Published : 10/11/2017




















Yunmeng , 8 Heping Road; Economic Development Zone , Xiaogan, Hubei CHINA










Longliqi Biological Ind. Park , Changnan Village, Xinzhuang , Changshu, CHINA










NO 2 Huimin East Rd. , Rugao , Nantong, Jiangsu CHINA

Jiangxi Hengxiang Pharmaceutical Technology Co. Ltd.Date Published : 04/27/2017

Jiangxi Yuneng Pharmaceutical Co., Ltd. Date Published : 04/08/2016





























Zibu Fine Chemical Industry Park , Wannian County , Shangrao, Jiangxi CHINA










Hi-Tech Industrial Development District , Jian City, Jiangxi CHINA


MC Group Development Ltd. Date Published : 07/12/2016

Nanjing County Yideli Canned Food Co., Ltd Date Published : 09/06/2010




























1095 Duanmei Rd , Yingzhou District , Ningbo, Zhejiang CHINA










Mashan, Longshan Town , Nanjing County , Zhangzhou, Cn-35 CHINA

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10













40 C - - -- Formula Prod (Baby) Date Published: 09/06/2010










40 M - - -- Infant Formula Raw Material Date Published: 09/06/2010























Ningbo Gooey Bio-Technology Co., Ltd. Date Published : 06/17/2016

QINGDAO DONGJIANG GUOSHU FOOD CO.,LTD Date Published : 04/24/2017








52 E - - -- Infant Food Items Date Published: 09/06/2010





















NO. 166 Xinghailu , Ninghaixian , Ningbo, Zhejiang CHINA

Notes:All Drugs and Drug Products








East Guangzhou Road, North West Tuandao , Laixilu; Lai XI , Qingdao, ShandongCHINA

Notes:All Food Products





42 A - - -- Whole Edible Insects (adults and immature stages) Date Published: 04/24/2017

42 B - - -- Milled Edible Insect Products Date Published: 04/24/2017

42 C - - -- Edible Insect Bars Date Published: 04/24/2017

42 D - - -- Edible Insect Bakery Products Date Published: 04/24/2017

42 E - - -- Edible Insect Candy With Chocolate Date Published: 04/24/2017

42 F - - -- Edible Insect Candy Without Chocolate Date Published: 04/24/2017

42 G - - -- Edible Insect Capsules Date Published: 04/24/2017

42 H - - -- Edible Insect Granola or Trail Mix Date Published: 04/24/2017

42 I - - -- Edible Insect Jerky Date Published: 04/24/2017

42 J - - -- Edible Insect Ice Cream and Related Products Date Published: 04/24/2017

42 K - - -- Edible Insect Oils Date Published: 04/24/2017

42 L - - -- Edible Insect Smoothies Date Published: 04/24/2017

42 M - - -- Edible Insect Soups Date Published: 04/24/2017

42 N - - -- Edible Insect Spreads And Pastes Date Published: 04/24/2017

42 O - - -- Edible Insect Beverages Date Published: 04/24/2017

42 P - - -- Edible Insect Protein: Simulated Meats and Tofu Date Published: 04/24/2017

42 Q - - -- Edible Insect Salts and Spices Date Published: 04/24/2017

42 R - - -- Edible Insect Products N.E.C. Date Published: 04/24/2017





















Qingdao Hairong Foodstuff Co., Ltd Date Published : 11/28/2017


























Zone Park , Xigu Village Inside Beiguan Industrial , Jiaozhou City Qingdao, ShandongCHINA
















Qingdao Jinfeng Pharmaceutical Co., Ltd Date Published : 10/21/2016



































NO 3 Yantai Road , Laixi, Qingdao CHINA







SHANDONG HONGDA GROUP Date Published : 12/08/2017

























NO. 59 Nanshannanlu , Rongcheng , Weihai, Shandong CHINA


















Shandong Xinhua & Longxin Chemical Co. Ltd. Date Published : 05/25/2016

































NO. 299 Yixi Road , Linzi District , Zibo, Shandong CHINA









Shanghai Chuangi Food Co. Ltd. Date Published : 10/12/2010






















138 Kangjian Road , Xuhui District , Shanghai, CHINA

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10




















Shanghai Chuanqi Food Co., Ltd. Date Published : 10/12/2010


































No. 96 Jianlu Road , Shanghai, CN-31 CHINA









Shanghai Kejing Cleaning Products Co. Ltd. Date Published : 10/20/2017

Shanghai Wei Chuan Foods Industrial Co., Ltd. Date Published : 11/21/2014























Building A Room 703 , 1500 Longwulu; Xuhui , Shanghai, Shanghai CHINA

Notes:All Drugs and Drug products









No.88, Cao Xin Rd., Caowang Town , Development Area, Jiading District , Shanghai,Shanghai CHINA








Shenzhen Happy Pharmaceuticals Ltd. Date Published : 10/14/2016

Shijiazhuang Polee Pharmaceutical Co., Ltd. Date Published : 11/27/2017
























NO. 8 Xingfu Road Gudi , Industrial Zone , Weifang, Shandong CHINA










Industrial Park Xinzhaidian Town , Shijiazhuang, Hebei CHINA








Taisan City Chemical Pharmaceutical Co., Ltd. Date Published : 10/19/2015

Taizhou Xinyou Pharmaceutical & Chemical Co., Ltd.Date Published : 01/25/2016






















No. 98 Longzhou Road , Taicheng Town , Taishan City , Guangdong CHINA










NO. 258 Jiaojiang , Taizhou, Zhejiang CHINA









Tianjin Zhongan Pharmaceutical Co., Ltd. Date Published : 02/09/2016


02 - - - -- Whole Grain/Milled Grain Prod/Starch Date Published: 02/09/201603 - - - -- Bakery Prod/Dough/Mix/Icing Date Published: 02/09/201604 - - - -- Macaroni/Noodle Prod Date Published: 02/09/201605 - - - -- Cereal Prep/Breakfast Food Date Published: 02/09/201607 - - - -- Snack Food Item Date Published: 02/09/201609 - - - -- Milk/Butter/Dried Milk Prod Date Published: 02/09/201612 - - - -- Cheese/Cheese Prod Date Published: 02/09/201613 - - - -- Ice Cream Prod Date Published: 02/09/201614 - - - -- Filled Milk/Imit Milk Prod Date Published: 02/09/201615 - - - -- Egg/Egg Prod Date Published: 02/09/201616 - - - -- Fishery/Seafood Prod Date Published: 02/09/201617 - - - -- Meat, Meat Products and Poultry Date Published: 02/09/201618 - - - -- Vegetable Protein Prod Date Published: 02/09/201620 - - - -- Fruit/Fruit Prod Date Published: 02/09/201621 - - - -- Fruit/Fruit Prod Date Published: 02/09/201622 - - - -- Fruit/Fruit Prod Date Published: 02/09/201623 - - - -- Nuts/Edible Seed Date Published: 02/09/201624 - - - -- Vegetables/Vegetable Products Date Published: 02/09/201625 - - - -- Vegetables/Vegetable Products Date Published: 02/09/201626 - - - -- Vegetable Oils Date Published: 02/09/201627 - - - -- Dressing/Condiment Date Published: 02/09/201628 - - - -- Spices, Flavors And Salts Date Published: 02/09/201629 - - - -- Soft Drink/Water Date Published: 02/09/201630 - - - -- Beverage Bases/Conc/Nectar Date Published: 02/09/201631 - - - -- Coffee/Tea Date Published: 02/09/201632 - - - -- Alcoholic Beverage Date Published: 02/09/201633 - - - -- Candy W/O Choc/Special/Chew Gum Date Published: 02/09/201634 - - - -- Choc/Cocoa Prod Date Published: 02/09/201635 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 02/09/201636 - - - -- Food Sweeteners (Nutritive) Date Published: 02/09/201637 - - - -- Mult Food Dinner/Grav/Sauce/Special Date Published: 02/09/201638 - - - -- Soup Date Published: 02/09/201639 - - - -- Prep Salad Prod Date Published: 02/09/201640 A - - -- Baked Goods (Baby) Date Published: 02/09/201640 B - - -- Cereal (Baby) Date Published: 02/09/201640 D - - -- Veg (Baby) Date Published: 02/09/201640 E - - -- Fruit/Juice/Drink (Baby) Date Published: 02/09/201640 F - - -- Meat Prod/Comb Meat Dinner (Baby) Date Published: 02/09/201640 G - - -- Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 02/09/2016


Xiqing , 188 Fukang Road , Tianjin, Tianjin CHINA

40 H - - -- High Meat Dinner/Cheese Food (Baby) Date Published: 02/09/201640 I - - -- Fish-Seafood Prod (Baby) Date Published: 02/09/201640 J - - -- Egg Prod (Baby) Date Published: 02/09/201640 K - - -- Pudding/Custard (Baby) Date Published: 02/09/201640 L - - -- Soups/Soup Mix (Baby) Date Published: 02/09/201640 Q - - -- Pasta and Noodle Combination Dinners Without Meat

Date Published: 02/09/201640 X - - -- Market Basket Sampling Date Published: 02/09/201640 Y - - -- Baby Food N.E.C. Date Published: 02/09/201641 - - - -- Dietary Conv Food/Meal Replacements Date Published: 02/09/201642 A - - -- Whole Edible Insects (adults and immature stages)

Date Published: 02/09/201642 B - - -- Milled Edible Insect Products Date Published: 02/09/201642 C - - -- Edible Insect Bars Date Published: 02/09/201642 D - - -- Edible Insect Bakery Products Date Published: 02/09/201642 E - - -- Edible Insect Candy With Chocolate Date Published: 02/09/201642 F - - -- Edible Insect Candy Without Chocolate Date Published: 02/09/201642 G - - -- Edible Insect Capsules Date Published: 02/09/201642 H - - -- Edible Insect Granola or Trail Mix Date Published: 02/09/201642 I - - -- Edible Insect Jerky Date Published: 02/09/201642 J - - -- Edible Insect Ice Cream and Related Products Date Published: 02/09/201642 K - - -- Edible Insect Oils Date Published: 02/09/201642 L - - -- Edible Insect Smoothies Date Published: 02/09/201642 M - - -- Edible Insect Soups Date Published: 02/09/201642 N - - -- Edible Insect Spreads And Pastes Date Published: 02/09/201642 O - - -- Edible Insect Beverages Date Published: 02/09/201642 P - - -- Edible Insect Protein: Simulated Meats and Tofu

Date Published: 02/09/201642 Q - - -- Edible Insect Salts and Spices Date Published: 02/09/201642 R - - -- Edible Insect Products N.E.C. Date Published: 02/09/201652 B - - 06 Corn Husks (Food Related) Date Published: 02/09/201652 B - - 07 Snail Shells (Food Related) Date Published: 02/09/201652 B - - 08 Sausage Casings, Artificial (Food Related) Date Published: 02/09/201652 B - - 12 Bird's Nest Date Published: 02/09/201652 D - - -- Live Animals Date Published: 02/09/201654 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal) Date Published: 02/09/201655 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 02/09/201656 - - - -- Antibiotics (Human/Animal) Date Published: 02/09/201660 - - - -- Human and Animal Drugs Date Published: 02/09/201661 - - - -- Human and Animal Drugs Date Published: 02/09/201662 - - - -- Human and Animal Drugs Date Published: 02/09/201663 - - - -- Human and Animal Drugs Date Published: 02/09/201664 - - - -- Human and Animal Drugs Date Published: 02/09/2016

Tianjin Zhongxin Pharmaceutical Group Corp., Ltd. Date Published : 09/19/2017

Wellable Group Marine Biological & Chemical Co., LTDDate Published : 04/09/2014

65 - - - -- Human and Animal Drugs Date Published: 02/09/201666 - - - -- Human and Animal Drugs Date Published: 02/09/2016



















Longshunrong Pharmaceutical Factory , NO. 21 10th Avenue, Teda , Tianjin, TianjinCHINA










Dabao Development Zone , Shishi, Fujian CHINA

Notes:ALL food products; Problem(s): Firm refused FDA inspection


























52 B - - 02 Foreign Object (Food Related) Date Published: 04/09/2014

52 B - - 03 Pesticides, Chemical, Etc. (Food Related) Date Published: 04/09/2014

52 B - - 04 Water Related To Shellfish Growing Areas (Food Related) Date Published: 04/09/2014





















Wendeng Jinye Industrial Co., Ltd. Date Published : 11/02/2017

52 B - - 05 Food Packaging Material (Food Related) Date Published: 04/09/2014




52 B - - 10 Food Manu./Processing Machinery/Parts for Home/Commercial Use Date Published: 04/09/2014


52 B - - 99 Food Related Item, N.E.C. Date Published: 04/09/2014


52 Y - - -- Exhibit (Evidence Development) Date Published: 04/09/2014



68 - - - -- Animal Devices and Diagnostic Products Date Published: 07/08/2014


















Desc:ALL PRODUCTS (including Pharmaceutical Necessities; Drugs; Biologics;Devices - Human and Animal)Notes:Firm refused FDA inspection

Desc:ALL PRODUCTS (including Pharmaceutical Necessities; Drugs; Biologics;Devices - Human and Animal)Notes:Firm refused FDA inspection

No. 7 Baodelu , Wendeng , Weihai, Shandong CHINA






Wuhan Fulai Pharmaceutical Technology Co.,Ltd Date Published : 09/26/2017

Yixing City Xingyu Medicine Chemicals Co Ltd Date Published : 10/10/2017























Longxin Industrial Park 3 , Dongxihu , Wuyi, Hubei CHINA










Fufeng Industrial Zone , Fangqiao Town , Yixing, Jiangsu CHINA









Zhangzhou Tongfa Foods Industry Co., Ltd Date Published : 01/10/2014























Hongdai Industry Zone, Jiaomei Town , Longhai , Zhangzhou, Fujian CHINA






























37 - - - -- Mult Food Dinner/Grav/Sauce/Special Date Published: 01/10/201438 - - - -- Soup Date Published: 01/10/2014
































Zhejiang Bangli Medical Products Co., Ltd Date Published : 09/07/2016

































Huachuan Block , 118 South of Yuegui Road , Yongkang City, Zhejiang CHINA









CREDIN HELLAS S.A. Date Published : 04/24/2017



















GREECE

Industrial Area , Athinas 52nd , Ag. Ioannis Rentis, Peiraias GREECE


















Nan San (HK) Pharmaceutical Factory Ltd. Date Published : 07/19/2016













53 - - - -- Cosmetics Date Published: 07/19/2016
















HONG KONG

Hoi Bun Industrial Building , 6 Wing Yip Street, Unit C1, 10/F , Kwun Tong Kowloon,Hong Kong HONG KONG

Notes:All Drug and Drug Products;For industry code 53, only products found to bedrug products are subject to DWPE under this listing.

Notes:All Drug and Drug Products;



Sunbow Biotech Ltd Date Published : 01/27/2014

CF Pharma Ltd. Date Published : 12/08/2015




















610 Nathan Rd , Room 1318-19 13F Hollywood Plaza , Mongkok Kowloon, HONGKONG

HUNGARY

Ken utca 5 , Budapest IX, Budapest HUNGARY







Aadivighnesh Chemicals Pvt Ltd Date Published : 04/30/2015















INDIA

304 B Riddhi Siddhi Complex , M.G Road Sukar Wadi, Boravali E. , Mumbai, INDIA








Alcon Biosciences Pvt Ltd Date Published : 09/21/2017





















Plot A1, 2104 , Phase III, GIDC , Vapi, Gujarat INDIA



























33 - - - -- Candy W/O Choc/Special/Chew Gum Date Published: 09/21/201734 - - - -- Choc/Cocoa Prod Date Published: 09/21/2017

































Alex Industries Date Published : 09/13/2017


42 N - - -- Edible Insect Spreads And Pastes Date Published: 09/21/201742 O - - -- Edible Insect Beverages Date Published: 09/21/2017






































Basic Pharma Life Science Private Ltd. Date Published : 10/10/2017

Cadbury India Date Published : 10/28/2014




















Plot No 9109/4-5 Gidc Industrial Estate , Nr. Ion Exchange, Kanoria Chemical Road ,Ankleshwar, Gujarat INDIA










Plot No.146/B GIDC Estate , Opp. New Fire Station , Ankleshwar, Gujarat INDIA










2st P0khran Road , Thane, INDIA

Century Pharmaceuticals Limited Date Published : 07/28/2016

Cheryl Laboratories Pvt Ltd Date Published : 06/13/2016






























103-106, GIDC, Halol , Panchamahals, Gujarat INDIA










A-329/330, Ttc Indl. Area, Midc Mahape , Navi Mumbai, Maharashtra INDIA

Divis Pharmaceuticals Private Limited Date Published : 08/29/2016

Divis Pharmaceuticals Pvt Ltd Date Published : 08/30/2016





























Divi Towers, 7-1-77/E/1/303 , Dharam Karan Road, Ameerpet , Hyderabad, AndhraPradesh INDIA










Survey No. 10 Gaddapotharam Village , Jinnaram Mandal, Medakdist, INDIA


G. Amphray Laboratories Date Published : 08/30/2016

Harika Drugs Private Limited Date Published : 07/01/2016




























10/1 Midc Industrial Area , West , Ambernath, Maharashtra INDIA










5th Floor , 36/A Bhanu Enclave; Vengal Rao Nagar , Hyderabad, Telangana INDIA




Harika Drugs Private Limited Date Published : 07/01/2016

Kronox Lab Sciences Private Ltd. Date Published : 11/17/2017


























Gummadiala Village , Medak District, Andhra Pradesh INDIA










284 AT Dabhasa TAL Padra , Vadodara, Gujarat INDIA

Notes:All Drug and Drug Products;For Industry Code 54, only drug and drug productsare subject to DWPE under this notice.




Laxachem Organics Private Ltd. Date Published : 08/11/2016

Mahrshee Laboratories Private Ltd. Date Published : 11/22/2017



























D-2 MIDC Industrial Area , Amravati, INDIA










Plot No 3014/3015, G I D C , Industrial Estate , Bharuch, Gujarat INDIA





PHALANX LABS PRIVATE LIMITED Date Published : 06/15/2016

Silverline Chemicals Date Published : 06/29/2016














53 - - - -- Cosmetics Date Published: 06/29/2016









PLOT NO.74B, JAWAHARLAL NEHRU , PHARMA CITY, PARAWADA ,VISAKHAPATNAM, Andhra Pradesh INDIA










G.T. Road , Shingla Carpets Building , Tehsil, Panipat, Haryana INDIA




Suchem Laboratories Date Published : 04/30/2015

Suprima Cosmo Tech Date Published : 11/01/2016























Jalaram Party Plot , #10/13 Phase I; Service Road , Daskroi, Gujarat INDIA










26/A, Osiya Mata Compound , Reti Bunder Road, Kalher Village , Bhiwandi, Thane,Maharashtra INDIA

import alert 99-32 - pharmacompass.com · 2017. 12. 26. · import alert 99-32 ( n o t e : t h i s...

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