German CMO BBT Biotech Issued FDA Warning LetterBy
The US Food and Drug Administration (FDA) has posted a Warning Letter for BBT Biotech GmbH, a contract manufacturing organization, based in Baesweiler, Germany, for violations for good manufacturing practices (GMP) for active pharmaceutical ingredient (API) manufacturing. The letter was issues in response to a FDA inspection in May 2015.
The FDA cited the firm for failure to follow a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates. The agency also cited the company for failure to establish and follow a change management system evaluating all changes that could affect the production and control of its APIs and failure to evaluate the potential effect changes may have on the quality of its APIs. The FDA also cited the firm for failure to adequately investigate out-of-specification results. The agency also cited the company for failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data.