US FDA Warning Letters for inadequate Batch Records

Recommendation
29/30 April 2025
Hamburg, Germany
Batch Manufacturing Documents: from Preparation to Operational Excellence
The U.S. Food and Drug Administration (FDA) recently posted Warning Letters criticising incomplete batch production and control records.
For example, at a company in Spain, the inspector found
- white-out correction liquid
- unintelligible data
- missing information such as test results and the date of approval
- over written or crossed-out entries with "no signature, date, or explanation"
- no proof that a second person has reviewed record "for accuracy, completeness, and compliance with established standards"
Furthermore, FDA criticised a missing identity and strength testing, an inadequate stability testing programme and - of course - "Data Integrity Remediation".
As a conclusion, FDA stated that the company's "quality systems are inadequate" and placed the firm on Import Alert.
At a site in California (USA) an investigator found that the firm was not performing final reviews of batches manufactured by a third party manufacturer before disposition. Determining the suitability of each batch for release is an essential component of your QU responsibility.
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