fda enforcement inspections,trends q&a session with a recent fda investigator

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Rob Packard, Presidentwww.MedicalDeviceAcademy.com

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FDA Enforcement Inspections, Trends:

A Q&A Session with a formerFDA Investigator

http://www.medicaldeviceacademy.com/

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Our Speaker

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Leo J. LagrotteFormer ORA Investigator



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Question #1:You worked in the Tampa, FL office. My clients in the area mentioned that the office makes more regular visits than the target of 2 years. California seems to be another market with almost annual visits. Other regions have inspections less frequently that 2 years. Can you explain why Tampa and California are more frequent than the target of 2 years?



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Question #2Yesterdays’ presentation was about FDA recalls. If a manufacturer has a recall, should an inspection automatically be expected the following year? If not, what other factors impact the likelihood of an inspection?



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Question #3What’s the most common mistake you noticed in companies managing FDA inspections? How do you rectify it?



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Question #4What direction do you think FDA enforcement will take over the next 5 years related to Quality System inspections?



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Question #5Due to industry regulatory compliance trends, are FDA investigators receiving specific new training in QS areas that they have not received in the past?



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Question #6I hear more each year about the “eFDA”--or the automation of administrative tasks at the FDA. Do you think the FDA will ever switch from green and black bound notebooks to electronic devices such as tablets? Could this include photos?



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Question #7The Medical Device Single Audit Program (MDSAP) pilot has started, and the acceptance of the MDSAP reports in lieu of ANVISA audits by Brazilian regulators, Health Canada, Australia and the US FDA is exciting. Do you think MDSAP will dramatically reduce QSIT inspections?



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Question #8You perform a lot of mock-FDA inspections. What is the most valuable thing your clients have learned during your simulated QSIT inspections?



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Question # 9Many companies seem to use a memo to respond to FDA 483s, but what do you recommend to clients with regard to format and content of an FDA 483 response?



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Question #10You and I have both been helping foreign firms with responding to Warning Letters with automatic detention. For anyone that doesn’t know what an “automatic detention” is, could you please explain it? Also, could you please explain how the reaction to FDA 483s and warning letters should be different if the manufacturer is a foreign firm?



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Need help with regulatory compliance?

Rob Packard

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fda enforcement inspections,trends q&a session with a recent fda investigator

Health & Medicine

rob packard

fda inspections

fda recalls

fda enforcement inspections

fda investigators

us fda

simulated qsit inspections

quality system inspections