FDA 483 - Dercher Enterprises, Inc., DBA Gordon Laboratories - June 13, 2022

Dercher Enterprises, Inc., DBA Gordon Laboratories in Upper Darby, PA, was cited for four observations during an FDA inspection. The firm lacks a comprehensive stability testing program, leading to unsupported product expiration dates and inadequate sample storage. Additionally, the quality control unit's responsibilities and procedures are not fully documented or followed, particularly concerning vendor assessment and change control for product formulations and processes.