FDA 483 - Central Admixture Pharmacy Services, Inc. - July 31, 2023

The FDA inspected Central Admixture Pharmacy Services, Inc., an Outsourcing Facility in Phoenix, AZ, from June 21, 2023, to July 31, 2023. The inspection revealed multiple significant violations.

The Quality Unit failed to initiate investigations for at least 27 instances of data integrity concerns (e.g., shredded GMP documents, back-dating, lack of contemporaneous records) and lacked comprehensive procedures for reviewing audit trails and electronic data. For example, Rocuronium was frequently re-run for UPLC due to system suitability failures without written justification.

The firm lacked stability data to support sterility for sterile drug products throughout their labeled expiration dates, and some products, like Oxytocin, failed potency specifications during stability testing.

Production and process controls were deficient. The firm lacked scientific justification and procedures for re-introducing raw materials into the (b)(4) chamber multiple times for sterile compounding. Additionally, the firm did not follow its validated method for loading materials onto (b)(4) carts, potentially compromising decontamination.

Aseptic processing areas exhibited visible dirt, including rusted casters on mop carts and orange-brown stains on ISO 7 cleanroom floors. ISO 5 hoods used for sterile drug production had scratches on their back walls, making them difficult to clean.

Calibration of instruments was not consistently performed, with a particulate matter counter found past due for calibration. Labeling procedures were not followed, as pharmacy technicians,