FDA 483 - Oregon Compounding Centers, Inc. - August 28, 2014

This FDA Form 483 details ten observations from an inspection of a facility manufacturing sterile injectable drug products.

**Facility and Operations:** The facility produces sterile injectable drug products, including Alprostadil/Lidocaine, Methylcobalamin, Glutathione, Calcium Gluconate, Sodium Phosphate, Selenium, MSM, Ascorbic Acid, Mitomycin, and Avastin. Operations involve ISO 5 hoods, ISO 7, and ISO 8 areas, with processes including sterile filtration, filling into various vial sizes (1mL to 100mL), syringe-to-syringe transfers, and filling from beakers using a pump.

**Violations and Observations:**

1. **Aseptic Techniques:** Inadequate aseptic techniques were observed, including handling non-sterile components in an ISO 5 hood without disinfection, touching non-sterile materials with sterile gloves, and re-using non-sterile items. An operator also used an incompatible filter, causing product leakage, and introduced a new filter into the ISO 5 hood without sanitization. 2. **Sterilization Process Validation:** The high-risk process simulation testing (media fills) did not cover all aseptic filling operations, including various vial sizes (30, 50, 100mL) that are sterilized in-house, syringe-to-syringe transfers, and filling from beakers with a pump. Moist heat sterilization (autoclave) for stoppers and term