Most Common FDA 483 Violations in 2023
July 29th, 2024 // 2:20 pm @ jmpickett
No one in the pharmaceutical or medical device industries relish receiving an FDA 483. However, if you get an FDA 483 with inspection observations, keep in mind that most citations are often overlapping, similar, or basically the same item applied to different parts of the business. For 2023, the most common FDA inspection observations are listed below, as well as how many there were that year:
- Insufficient documentation of procedures, quality control measures, or testing. 241 FDA observations between 2021 and 2023.
- Inadequate personnel training in QC measures or relevant procedures. 55 FDA observations between 2021 and 2023.
- Insufficient or inadequate investigations or correction of complaints or deviations. 187 FDA observations between 2021 and 2023.
- Not following established protocols or procedures. 39 FDA observations between 2021 and 2023.
- Facility or equipment deficiencies that may affect product quality or safety. 85 observations between 2021 and 2023.
- Improper or lack of process validation or validation of equipment. 44 observations between 2021 and 2023.
- Insufficient or inadequate testing of raw materials or products. 54 observations since 2021.
- Not properly handling, storing, or labeling materials. 8 FDA observations between 2021 and 2023.
- Not maintaining logs or records adequately. 38 FDA observations between 2021 and 2023.
- Not correctly reporting adverse events. 24 observations between 2021 and 2023.
