The FDA Warning Letter Report for Fiscal Year 2025
The number of warning letters published in fiscal year 2025 breaks last year's record: a total of 112 warning letters appeared on the FDA website, describing GMP deficiencies with reference to 21 CFR 211. This is the highest number of warning letters published in over 20 years.
In terms of content, the trend in the most frequently cited GMP violations continues from previous years.
The diagram in Figure 1 shows the top ten GMP deficiencies in the warning letters for FY 2025.
As in FY 2024, deficiencies relating to "Responsibilities of quality control unit" (211.22) and "Testing and approval or rejection of components, drug product containers, and closures" (211.84) were found most frequently in over half of the inspected production facilities.
This was followed by cGMP violations in the following areas:
- 211.100 Written procedures, deviations
- 211.166 Stability Testing
- 211.165 Testing and release for distribution
- 211.192 Production record review
- 211.160 Laboratory Controls - General Requirements
- 211.42 Design and Construction Features
- 211.113 Control of microbiological contamination
- 211.67 Equipment cleaning and maintenance
- 211.188 Batch production and control records
A look at GMP violations relating to building technology, as described in the warning letters issued over the last six fiscal years, reveals an interesting upward trend. In 22% of cases, inspectors found production facilities that did not comply with GMP and did not meet the requirements of Section 211.42 Design and Construction Features. GMP inspectors found these deficiencies predominantly at sites where aseptically manufactured drug products were produced.
Recommendation
10/11 February 2026
Handling of Foreign Particles in APIs and Excipients - Live Online Training
Figure 1: Top ten GMP violations in fiscal year 2025
Below are some examples of such common violations:
- There are no procedures for environmental monitoring in aseptic areas
- Cleaning and disinfection procedures in sterile areas are not validated
- Non-sterile items in aseptic areas
- Rough, hard-to-disinfect surfaces in the clean room
By far the most common deficiency concerns monitoring and disinfection procedures, which in most cases are either missing or, if present, insufficiently described.
This correlates with the quality assurance unit's insufficient adoption of responsibility for this area, as described in 211.22, which is also the most frequently cited GMP deficiency in this fiscal year.
Recommendation
Heidelberg, Germany10/11 February 2026
Combination Products
Data and statistics on warning letters
As part of its regular systematic analysis of warning letters published in each fiscal year regarding violations of cGMP, CONCEPT Heidelberg compiles statistics in the form of "Top ten lists of the most common GMP violations".
| Once completed, these documents will be available in the ECA members area. |
About the Author
Dr Gerhard Becker is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy in analytical and compliance topics.
