FDA 483 - Valgene Incorporated dba Cape Drugs - October 07, 2015

This FDA Form 483 documents significant deficiencies at a facility producing sterile drug products, including Glutathione 200mg/ml Injection, ALFA-2B 1million unit/ml ophthalmic, Triamcinolone diacetate Injection, Dexamethasone acetate Injection, TriMix Injection, HCG Injection, Methylcobalamin Injection, and Hydroxyprogesterone Injection.

Key violations include: 1. **Lack of Aseptic Procedures and Practices:** Observed instances of bare-hand contact with disinfected items, improper glove donning, inadequate disinfection of materials entering the hood, and operators entering/exiting cleanrooms without appropriate gowning. No established gowning procedures. 2. **Unvalidated Sterilization Processes:** Sterilization processes for products like Triamcinolone diacetate Injection and Dexamethasone acetate Injection are not validated. Sterilization duration is inadequate, not always documented, and no procedures exist. No media fills have been conducted. 3. **Inadequate Laboratory Testing:** Sterility and endotoxin testing are not consistently performed on all sterile products. Endotoxin test results were unavailable for nine months. In-house sterility testing lacks anaerobic media and sufficient incubation time, and validation data is absent. 4. **Improper Container Preparation:** Containers for sterile drug products, such as Glutathione 200 mg/ml Injection, are not adequately cleaned, sterilized, or processed to remove pyrogens. 5.