From ECA Academy

The systematic analysis of the GMP deficiencies recorded during an inspection reflects, on the one hand, what FDA inspectors focus on and, on the other hand, provides clues for preparing for an upcoming inspection by the FDA. In the fiscal year 2022 (Oct. 2021 – Sept. 2022), a total of 42 Warning Letters were sent to medicinal product manufacturers, each explicitly describing the GMP deficiencies in connection with the paragraphs of 21 CFR 211.

The 10 most frequently cited GMP “sins” are documented on the ECA Academy website.