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

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

**Stability Program and Testing:** The firm's stability program for drug products lacks reliable test methods. Specifically, the 90-day Beyond Use Date (BUD) for Rocuronium Bromide 10mg/ml 5ml syringes is not supported by adequate stability data. A contract laboratory used an inappropriate test method, measuring Bromide instead of the active ingredient Rocuronium, to determine potency. This invalid data was used to assign BUDs for Rocuronium Bromide lots manufactured and released between 11/27/2017 and 01/12/2018. The firm failed to investigate or risk assess the impact of this invalid potency test method. Furthermore, the firm does not perform potency testing on each lot of finished drug product prior to release, relying solely on initial stability studies.

**Sterilization Process and Aseptic Conditions:** Procedures to prevent microbiological contamination of sterile drug products are inadequate. * **Environmental Qualification:** The system for qualifying ISO 5 Laminar Air Flow Hoods (LAFHs) lacks assessment of air flow patterns under dynamic conditions for all equipment and component configurations. * **Aseptic Technique:** Observations on 2/12/2018, 2/20/2018, and a video review from 2