FDA 483 - SCA Pharmaceuticals, LLC - March 05, 2018

The FDA Form 483 details multiple deficiencies observed during an inspection of a drug manufacturing facility.

**Facility and Operations:** The facility compounds sterile drug products, including Rocuronium Bromide, Labetalol HCl, Hydromorphone, and Fentanyl syringes. Operations involve ISO 5 Laminar Air Flow Hoods (LAFHs), ISO 7 Compounding Rooms, and ISO 8 areas.

**Violations and Observations:**

* **Stability Program and Testing:** The written stability program lacks reliable test methods. Specifically, the 90-day Beyond Use Date (BUD) for Rocuronium Bromide 10mg/ml 5ml syringes is unsupported by valid stability data. A contract laboratory used an inappropriate test method, measuring Bromide instead of the active ingredient Rocuronium, for lots manufactured and released between 11/27/2018 and 01/12/2018. The firm failed to investigate or risk assess the impact of this invalid method. * **Sterilization Process Validation:** The sterilization process lacks adequate validation. The system for qualifying environmental conditions in ISO 5 LAFHs does not assess airflow patterns under dynamic conditions for all equipment and component configurations. Dynamic smoke studies were not conducted for all relevant setups. * **Aseptic Technique:** Multiple instances of poor aseptic technique were observed during sterile drug compounding: * Compounding technician blocking