FDA 483 - Valgene Incorporated dba Cape Drugs - January 22, 2018

This FDA Form 483 documents observations from an inspection of a facility producing highly potent drugs, including Progesterone, Testosterone, Estradiol, Estriol, or combinations thereof, using powder Active Pharmaceutical Ingredients (APIs) and other excipients. The firm also compounds oral and topical drug products for human and veterinary use, some of which are made using water.

Several violations were noted: 1. **Equipment and utensil cleaning and maintenance:** Utensils, specifically capsule-filling metal and plastic plates, used for highly potent drugs are not dedicated and are not adequately cleaned with appropriate cleaning agents before use on non-potent drug substances. The firm uses household dish liquid detergent and potable water for cleaning utensils used with highly potent substances. No cleaning procedure is established to prevent cross-contamination of shared utensils. 2. **Equipment design and location:** Powder-hoods used for processing drug products lack maintenance and qualification records to ensure intended operation. These hoods are equipped with non-pharmaceutical grade filters, posing a cross-contamination risk. They are used for both highly potent (e.g., Progesterone, Testosterone, Estradiol) and non-potent (e.g., Budesonide, Lidocaine, Benzocaine) drug products and are not adequately designed for cleaning between operations involving these different potencies. 3. **Component identification testing:** Specific identification tests are not conducted on components accepted based on supplier reports. Specifically, there is no documentation of analytical