A comprehensive GMP intelligence program includes monitoring health authority enforcement actions including U.S. FDA forms 483, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, MHRA annual summaries of inspection deficiencies, and EU reports of GMDP noncompliance. In addition to enforcement actions, a comprehensive program includes monitoring new or revised laws, regulations and guidance. This article focuses on US FDA data presenting the most recent publication of FDA GMP drug inspection data, which address drug inspections conducted in FY2021. I examine data from FY2021 and evaluate six years’ worth of trends in drug GMP inspection enforcement. For additional data on years before 2016, please refer to an article published last year.

The presentation of some data herein differs from data presented on the FDA website, even though it uses the same raw data. For example, I combine all observation listings at cite 21 CFR 211.42(c) into a single value, rather than identifying them in separate line items.

The data do not represent the FDA’s complete collection of inspection observations for the year. In past years, these data represented approximately one-third of all forms 483 issued, so conclusions must be tempered by the incomplete nature of the data. The data include only forms 483 issued through FDA’s electronic system; it does not include forms 483 issued to API manufacturers because §211 is not applied to those manufacturers or Forms 483 that are issued outside of the electronic system.

In addition to the FY2021 update and trends from previous five years, we include a tabulation of inspection observations other than 21 CFR 211. This includes the following data for the past five years:

  • 21 CFR 212 (PET drugs)
  • 21 CFR 310 (New Drugs)
  • 21 CFR 314 (Applications for FDA Approval to Market a New Drug)
  • 21 CFR 329 (Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug and Cosmetic Act)
  • 21 CFR 361 (Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research)
  • Federal Food, Drug and Cosmetic Act, section 501, Adulterated Drugs and Devices
  • Federal Food, Drug and Cosmetic Act, other sections

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FY2021 483 observations report

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