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

An FDA inspection was conducted at Valgene Incorporated dba Cape Drugs from November 8 to December 2, 2021, focusing on their production of sterile and non-sterile drug products. The inspection resulted in several significant observations detailed in an FDA Form 483, indicating potential deviations from current good manufacturing practices. Key issues included insufficient disinfectant contact time in the ISO 5 classified laminar flow hood, which did not meet internal procedures or manufacturer guidelines. Additionally, the facility featured difficult-to-clean, particle-generating equipment, specifically a bench with exposed wood-like material within both ISO 5 and ISO 7 classified areas. The facility design also allowed lower-quality, unclassified air to enter ISO 7 classified buffer rooms through pass-throughs. Furthermore, ISO 5 classified aseptic processing areas were not adequately certified under dynamic operational conditions, as air visualization studies (smoke studies) failed to incorporate materials typically used during sterile production. These observations highlight concerns regarding contamination control and aseptic processing, falling under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Valgene Incorporated dba Cape Drugs is expected to address these findings by implementing comprehensive corrective actions to ensure product quality and patient safety.