inspection report for blue bell, brenham
TRANSCRIPT
-
8/9/2019 Inspection report for Blue Bell, Brenham
1/4
SEE REVERSE
OFTHISPAGE
EMPLOVEE(S) SIGNATIJRE
Frans E. Mercado, Inve,tiqat or
Hung V. Le , I nves
ti
ga t or
Daniell e
L
yk e
, I nvestigator
J813ie
M.
Bumpas Investigator
Haba
cucV. Barrera,
I nve
st ig
at or
_
d_. ....
t : : : J ~
..
. f
_
Ch
a
r les
B. SteiNilil l
e r
, I nvestigator
0 /::::/
F
ra
nkl in R.
Harris,
Investig-ator
Qe
oise
Connel ly
Inve.stiqator
Silatina
J\
Alridge
, I nvlis
t1ga
t or
Massoud Motaned, In
vest
i
gato
r
Matthew R.
Maddox ,
Investig ator
I'REVIOOS SDITlON
OBSOLETB INSPECTIONAL OBSERVATIONS
DAlE
ISSU
e
/ 201
PAGE 1
OF4PAG
DEPARTMENT OF BEALmAND HUMAN SERVICES
FOODANDDRU
G NUNffiTR TI
ON
asTRIC
T ADDRE
SS
AAI> PHONE NUMBER
DATE( )
OF NSPECTION
4040 Nor th Centra l Exp r e
ssw
ay, S
ui te
300 0
3/1
6/2015 - 05/
01/
20
15
*
FE! NUMBER
Dallas
,
TX
75204
(214) 2
53-5
200 F
ax:
(214) 253- 5314 1682009
Industry
Inf
o
rmation
: www.fda .
gov/o
c / i ndu s t r y
AND Ti LE OF I
NO
MOVAL TOWHOM REPaUISSUEO
TO:
Pau l
W.
Krus
e,
C
EO
FIRM
NAM
E SIREETADDRESS
Blue Bel
l
Cr
eamer
ie s
, L. P.
Rd
OfTY, STATE,
ZIPOOile
COI.J
N
mV
Brenham, TX 77833
-4 4
13
Ma
nu
f
ac
turer
This document lists obs
ervations
made by the
FD
A
representative(s
) dwing the
inspection
of
your
facility.
They are
inspectional
observations, and do not represent a final
Agenc
y determination regarding your compliance. I fyou
have
an objection regarding an
observation, or have implemented, or plan
to
implemen
t, corrective
action in response
to
an observation
,
you may
discuss the objection
or
action with the
FDA representative(s)
during the
inspection
orsubmit
this
information
to
FDA
at the
address
above. I fyou have any
questions,
please
contact FDA at
the
phonenumber and
address
above.
DURING
AN
INSPECTION OF YOUR FIRM
WE OBSERVED:
OBSERVATION 1
Failure to manufacture
food
s
unde
r conditions
and controls necessary to
minimize the potential for growth
of
microorganisms.
S p e c i ~ c a l l y
The
foll
owing lots of
products, which were manufactured ontiiQJ
Iinellbetween
8/29/14 and 1121115 and subseque
ntly
distributed into
commerce,
were
sampled
by your fum
and found
positive for
Listeria
monocytogenes
• Great Divide Bar (Bulk packaging), manufactured on 1/12/15, lot
011217A,
and distributed between 1/13/
15
-
2/10/15.
• Chocolate
Chip
Country Cookie (Bulk Packaging), manufactured on 01/20/15, lot 01201
7A,
and distributed
between 1/20/15-2/11/15.
Additionally, your fum.ceased production on
1/
30115, to undergo routine cleaning and overhauling of[GJIQJ l ine On
2/13/
15
, your firm received notification from
DSHS
of your products positive for
Listeria monocytogenes.
Prior to resumin
operations on this line, your firm swabbed thegplLine.equipment and found the following listeria positive swabs:
• 2/19/15, inside drain ofthe freezer tunnel (non-food contact surface) ofthetiiQJ lin
• 2/21115, the outside drain of the freezer tunnel (non-food contact surface) ofthe[GJIU lin.
On 2/23/15 , your fum resumed o
pe
rations on
th4i l l l l l in
continuing to manufacture
on
3/2/15,
3/3
/15, 3/4/
15
, 3/5/
15
,
3/6
/15,
and
3/
9/15
. After
each of
these manufacturing
days your ~ j
routine
and
Hovvever,
on 3/9/15, your firm found Listeria [ i i i Jgenes positive swabs · • • in ~ ~ o dn
contact surface) and in the underside • • chainsprocket (food contact
surface)
. During line as
manufacturing Sour Pop Apples (lot# 030917A). However, the Sour Pop Apples (lot# 0309 1
7A)
were never offered
:fo
r
sale
-
8/9/2019 Inspection report for Blue Bell, Brenham
2/4
EMP
l.OYEE(S) SIGHA11JRE ·
DATE ISSUED
r a n ~
E. Morcedo, Invo.atigator
ung V. Invest iga tor
Dan1eUe Lyke, Invest1ga1:or
Jamie
M.
Blllllpas, Inve
stiqa1:or
abacuc V. Bar
rera,
I
nves
t
iga tor
· SEE REVERSE
Charles B.
StQinmiller,
I n v e s t i < ~ a t o r
,
05/01/2015
Franklin R. Harr is , Inve.stigator
OF THIS
PAGE
Dani3e
Connel
ly, Inve:.tigato.r
Sil'etina R.
1\.lridge,
Inve.,ti
gator
Massoud
Hotalled, I n v e s t i < ~ a t o r
MattllGW R. Maddox, I
nvestigator
FOR\\f
FDA
483 (09
198)
PREVIOUSBDmON OllSOLI TE
INSPECITONAL OBSERVATIONS PAGI!20P4
PAGI S
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND D
RUG AD
MINISTRATION
DIStRICT
ADDRESS
AND PHONE NUMI ER
DATE($) OF
I
NSPECI'ION
4040 North
Central
Ex
pressway
,
Suite 300
03/16/2015 - 05/01/2015 *
FEI
NU
IIBER
Dallas , TX
75204
(214) 253-
5200
Fax:
(214) 253-5314 1682009
Industry
Information: www . f da .
gov/oc/indus
t ry
NAME AND TTT1.EOF NDIVIDUAL TOWHOM REPCRT
ISSUED
TO:
Paul w. Kruse,
CEO
FIRM
N tE
STREET ADDRESS
Blue Bell Creameries , L. P. 1101
Blue
Bell Rd
CtlY, STAlE,
2JPCOOE,
COUNlRY
lYPE
-
8/9/2019 Inspection report for Blue Bell, Brenham
3/4
EMPLOYEE{S) SlGNATIJRE DAlE ISS\JED
Frana
E. Mercado, Investigator
~ ~
fung V. Le, Investigator
Dan.
i e l le
Lyke, I nvestigator
Jalllie M. BUII\pas , Investiga
tor
_
Habacuc V.
Barrera,
I nvest igator tJ
EE
REVERSE
Charles
B. t e i n m i Inve st igato r f
Franklin
R
Harr is ,
I nvort igat o r
05/01/201
5
OF THIS
PAGE
~ i s Conne y,
In
ves t iga to r
Shat1na
R.
Alr!dqe, In
vestigator
Ma.ssoud Motaited, In v
est iga
tor
Mattb.ew R. Maddox, I nvestigator
FORM
IDA
483 (09/08) PRBV OUS SOITION OBSOLII'I'E INSPECTIONAL OBSERVATIONS PAOE30F4PAGES
DEPARTMENTOFBEALTHANDHUMAN SERVICES
FOOD AND DRUGADMINIS TION
DISTRICT AOORESS AND PHONE NUMBER
DATE(S) OF INSPEC110N
4040
North
Central Expressway,
Sui t e 300
03/16/2015
-
05/01/2015*
TRA
FE NUMBER
Dallas , TX
752.04
(214)
253-5200
Fa
x:
(214)
253-5314
1682009
Indust ry
Information: www. f da.gov/oc/
in
dus t ry
NAME AND OF INDIVIDUAL TO WHOM REPORT ISSUED
TO:
Paul
W. Kruse, CEO
ARM NAMe
SlREET
ADDRESS
Blue Bel l
Creameries ,
L.P.
1101
s Blue
Bel l Rd
CITY, STATE, ZlPCOOE,COUNTRY 1'fPE T ~ T
1NSPECIED
Brenham
,
TX
77833-4413 Manufacturer
thatwe observed dripping directly into ice cream products:
On 3/17/15, we observed condensate drip on l ine.ocated on the
3rd
floor in production
areatfthe
firm. The drip was
falling from eachofthe
! l u e
hoses into the stainless steel mold. After the drip would fall on e molds, the molds
containing the drip were tiled with mix berry ice cream (lot 031717M).
On
3/18/15, we observed condensate above the filler on Pint line ocated on the I" floor in production are4i The
condensate was dripping directly into pints
ofmint
chocolate ice cream (lot 0318170).
On 3/
18/15,
we observed condensate on the filler on
112
Gallon
limlllocated
on the first floor in production
r e a ~ e
condensatewas dripping directly into
112
gallons
of
Cookies 'n Cream (lot 031817H).
On 4/21/15, we observed condensate drip on top
of
closed boxes
ofice
cream sandwich lids. The boxes containing ice cream
sandwich lids were staged in the sandwich mezzanine room on the second floor of the firm, under stainless steel ice cream
lines which feed ice cream into sandwich ; ruct ion lines h lids are an ingredient used in the manufacture
of
ice cream sandwiches.LinesMIDJIJ , manufacture Varu. a San "ches, Mini Sandwiches (vanilla), and double
vanilla sandwiches.
OBSERVATION 4
Failure to clean food-contact surfaces as frequently as necessary to protect against contamination offood.
Specifically,
On 3/16/15,
we
observed alllofthe ingredient hoppers in blending room llwere not kept clean. The underside of the hopper
lids were caked with emulsifiers and stabilizers which had mixed with the humidity found in the room These ingredients are
added
to
blenderlatongwith other ingredieni such as cocoa powder, and blended with raw milk. prior to entering the High
Temperature Short Time pasteurizer. Blende : room is found on the first floor of the facility
OBSERVATION
5
Failure
to
wear beard covers in an effective manner.
Specifically,
http:///reader/full/Mattb.ewhttp:///reader/full/Mattb.ew
-
8/9/2019 Inspection report for Blue Bell, Brenham
4/4
~
... 7
OF THIS PAGE
SEE
REVERSE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD
AND
DRUG ADM INISTRATION
OISTRCT
ADDRESS AND
PHONE
NUMBER
DATE(S) OF ti PECI ION
·
4040 North Central
Expressway, Suite 300 03/16/2015 -
05/01/2015
*
FEI NOAIBER
Dallas, TX
75204
(214)
253-5200 Fax : (214)
253-5314 1682009
Indus
t
ry
Information : www. fda . gov/oc/ind
ustry
NAM
"
AND liTL.E
Of INDMOIJAI.
TO
WHOM REPORT
ISSUED
TO: Paul W
Kruse, CEO
ARM
NAME
SIREET
ADDRESS
Blue Bell
Creameries,
L.P. 1101
s Bl ue
Bell Rd
CITY,
STATE,
ZIPCODE, COUNTRY
TYPE
ESTI\Ili.ISHMENT
INSPECTED
Brenham,
TX
77833-4413
Manufacturer
On
3/16/15, we observed 6 employees with beards wear protective beardnets without covering the mustache portionof their
beards. The employees were in various areas ofthe facility, including the HTST area, and in areas where the firm was
actively producing products.
OBSERVATION6
Fai
lure to maintain buildings in repair sufficient to prevent food
from
becoming adulterated.
Specifically,
-
n 3/16/15, we observed paint on the ceiling vent directly above blender& in the Blender& andlfR.oomwas chipped and
cracking. Blender& is used to add liquid ingredients and sugars into the raw milk product before it enters the
Temperature Short Time pasteurizers.
We
also observed that the door guards on the door
at
the entrance to the • •
equipment
room
in productionar4h ddeep grooves, preventing the surface
of
the
doo
r guards to be easilycleaned
..
DATES OF
INSPECTI
ON:
03/16/2015(Mon), 03/l7/2015(Tue), 03/18/2015(Wed) ,
03
/l9/2015(Thu), 03/20/2015(Fri), 03/30/201
5(Mon)
, 03/3l/2015(Tue),
04/02/2015(Thu),
04/06/20
15(Mon), 04/08/2015(Wed),
04/l3/2015(Mon)
, 04121/2015(Tue),
05/0
l/2015(Fri)
gator
EMPI..OYEE(S)
SIGNATURE
F
rans
E.
Mercado, In
v
es t
i ga tor
flung V.
1
Investiga t or
Daniel le L
yke,
Investigator
J8111ie M. Bumpas, I
nvestigator
Habacuc
V.
a r r e r a ~
Inv
es
t igator
Cbarles
B.
S einmi l le r , I
nves
Fr anklin R. Harr
i s
,
lnvG::otiqator
Connel l y,
Inves
t
iga tor
nise
S a t 1na R. Al r
1dge,
I n
vestigator
Massoud Motamed, I nvest igator
Matthew R. Haddox, Investigator
DATE
ISSUED
05/01/
20
15
FORM II1>A 483(09188)
PREVIOUS
EDmON DBSOI..ETB
INSPECI'IONAL OBSERVATIONS
PAGE40F4 PAOES