FDA 483 - B & B Pharmaceuticals, Inc. - October 26, 2018

An FDA inspection of B & B Pharmaceuticals, Inc., an API repackager in Englewood, CO, revealed significant deficiencies in their operations. The firm demonstrated a lack of effective cleaning validation, poor batch record management, and inadequate deviation control. Furthermore, issues were identified with the independence of the Quality Unit, complaint handling, and employee training, indicating a broad failure to adhere to Good Manufacturing Practices.