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# Warning Letter ‘Top 10’ GMP Deficiencies
- URL: https://www.fdaweb.com/warning-letter-top-10-gmp-deficiencies/
- Published: 2022-11-15T12:00:00.000Z
- Updated: 2026-09-14T18:06:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153201

An analysis by the Germany-based ECA Academy of 42 FY 2022 FDA Warning Letters has identified the top 10 most frequently cited good manufacturing practice deficiencies. The 10 [listed](https://www.gmp-compliance.org/gmp-news/fda-warning-letters-of-the-fiscal-year-2022-the-top-ten-gmp-deficiencies?ref=fdaweb.com) are:

- responsibilities of the quality control unit (cited in 23 letters);
- product record review (19 citations);
- testing and release for distribution (17);
- deviations from written procedures (16);
- testing and approval or rejection of components, drug product containers, and closures (14);
- equipment cleaning and maintenance (13);
- stability testing (11);
- general requirements (10);
- automatic, mechanical, and electronic equipment (8);
- design and construction features (4);
- control of microbiological contamination (4); and
- batch production and control records (4).