FDA 483 - Clinical Apothecaries - November 20, 2013

On November 20, 2013, the FDA issued a Form 483 to Clinical Apothecaries, a compounding pharmacy located at 4087 Medina Rd, Medina, OH. The inspection, conducted from November 6-20, 2013, identified eight observations related to the firm's manufacturing and quality control processes for sterile drug products.

Key observations included: 1. **Inadequate Personnel Gowning:** Cleanroom technicians performing aseptic operations did not use sterile lab coats, masks, hair nets, or shoe covers. 2. **Insufficient Component Testing:** The firm accepted supplier analyses for components without performing identity tests or validating supplier reliability. Components for sterile drug products were not tested for purity, strength, quality, or total bioburden. 3. **Unvalidated Sterilization Processes:** Qualification studies were not performed on the firm's sterilizers (Asset# 4.030.1 and 4.040.1) used for drug products and utensils, including glassware. The sterilization process for drug products was not validated to assess impact on identity, potency, quality, purity, and stability. 4. **Lack of Finished Product Testing:** Not all lots of finished sterile drug products underwent sterility and/or endotoxin testing. Lots produced in quantities greater than 8 units were only periodically tested without established frequency. 5. **Inadequate Potency Testing:** Not all