13/14 December 2023
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
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.