FDA 483 - Valgene Incorporated dba Cape Drugs - December 02, 2021

An FDA inspection of Valgene Incorporated dba Cape Drugs in Annapolis, MD, a producer of sterile and non-sterile drug products, revealed significant deficiencies in aseptic processing and facility controls. Observations included insufficient disinfectant contact time, difficult-to-clean surfaces with exposed particle-generating materials, and facility design flaws allowing poor quality air into classified areas. Additionally, ISO 5 classified areas were not properly certified under dynamic conditions, indicating a high risk to sterile product quality.