Are you ready for an FDA inspection in 2022?

Today, we are releasing our Annual Report that highlights the most frequently cited FDA Inspection Observations of Fiscal Year 2021, preparing our subscribers for FDA inspections in 2022.

As in prior years, the most frequent failures relate to the lack of documentation of procedures and investigations in accordance with 21 CFR 211.22(d).

In a previous blog post, Are you ready for the New Year?, we identify 15 suggestions to help you prepare for your next FDA inspection.

fda inspection 2022

The team at GMP Trends would like to thank you for your commitment to quality and safety. We value your efforts and readership.

Together, letā€™s commit to quality in 2022. We are here to assist your regulatory procedures to best prepare for an FDA inspection in 2022.

Visit our Store and plan your 2022 quality strategy today.

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GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

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To get the most out of GMP TrendsĀ®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else! Every subscription provides the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format. Join the thousands of professionals who rely on GMP TrendsĀ® to keep them informed of the latest FDA Enforcement Trends!

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