US FDA Warning Letters for inadequate Batch Records

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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.