FDA 483 - B & B Pharmaceuticals, Inc. - November 18, 2019

An FDA inspection of B&B Pharmaceuticals, Inc. in Englewood, CO, an A/I repackager and distributor, revealed two repeat observations concerning significant deficiencies in their quality system. The firm lacked established specifications for primary packaging material review and release, and their product quality reviews were insufficient, failing to identify critical stability information. These repeat findings indicate persistent quality control issues.