FDA 483 - Apocus Inc - August 23, 2018

This FDA Form 483 documents observations from an inspection of American Specialty Pharmacy, a 503B Outsourcing Facility located at 2414 Babcock Rd Ste 106, San Antonio, TX 78229-4870. The inspection was conducted from August 14 to August 23, 2018, with Jacqueline E. Esqueda as the Pharmacist in Charge.

The inspection revealed six observations related to the facility's sterile drug production and quality control:

1. **Inadequate Validation of Aseptic and Sterilization Processes:** * Lack of a [(b)(4)] study to validate [(b)(4)] usage, which is less stringent than manufacturer recommendations, with no specification for the [(b)(4)] test in batch records for multiple sterile drug products (e.g., Zinc, Ascorbic acid, Dexpanthenol). * Media fills were not conducted under most challenging conditions, failing to simulate largest batch sizes and most difficult sterile processing methods; aseptic operators were not qualified on all media fills. * Smoke studies did not adequately mimic critical steps or challenging conditions of sterile drug processing (e.g., stoppering of vials, actual aseptic filling, ISO 5 airflow). * No validation of [(b)(4)] used to sterilize equipment (goggles, air sampling equipment) or [(b)(4)] used