FDA Issued More Warning Letters in FY2023
June 8th, 2025 // 2:25 pm @ jmpickett
In fiscal year 2023, FDA issued more warning letters than the year before. The agency issued 180 warning letters to drug and biologics companies, with 95 based on on-site audits. This was a rise from 165 warning letters in FY2022, with 74 audit-based. This increase in warning letters is a return to normal FDA operations after a slowdown in inspections, 483s, and warning letters during COVID.
Our review of recent FDA warning letter data also shows that the frequency of warning letter issuance rose between 2019 to 2023 per 100 inspections by 43%. This increase in warning letter issuance reflects the agency’s more targeted, risk-based approach to enforcement actions.
Most Common FDA Warning Letter Citations for FY2023
Our analysis of FDA warning letter data revealed the following common observations for FY2023:
Violations of cGMPs
- Inadequate process validation: A common 2023 warning letter citation was failing to establish written procedures for process and production control – 21 CFR 211.100(a). This violation was found 38 times in 94 warning letters based on inspections. This violation was common with OTC manufacturers that didn’t perform process validation.
- Facility and environmental problems: Several domestic drug companies were warned for a mold-type substance on air conditioning units and insects and animal waste found in bulk storage containers.
- Data integrity issues: About 16% of inspection-based warning letters delivered since early 2020 cited companies for not ensuring the integrity and accuracy of data to show drug effectiveness, safety, and quality. One company was cited for using an erasable marker for drug production records.
- Cross-contamination: Several hand sanitizer companies were warned for not separating industrial chemcials from products that were supposed to be used by humans. This is a lingering problem from nontraditional companies that entered the market during COVID.
Not Complying With Record Requests
A company in India – S&J International Enterprises – was warned for limiting or delaying access to records during an FDA audit. For instance, the company offered one fuzzy photo of drug product labels and claimed there were no laboratory non-conformance problems. They only later admitted to logs with OOS results after FDA discovered them.
Substandard Quality Unit Performance
Many 2023 warning letters noted major flaws in the roles, responsibilities, and authority of drug company quality units. Common problems were the complete lack of a QC unit or no written procedures to govern the QC unit. This was in violation of 21 CFR Part 11 rules. This problem was common with OTC and health product facilities.
