FDA 483 - Stewart Compounding Pharmacy - October 10, 2014

The FDA Form 483 details numerous deficiencies at a drug manufacturing facility, particularly concerning sterile drug production and quality control.

**Key Violations and Observations:**

* **Sterility and Endotoxin Testing:** The firm failed to conduct sterility and endotoxin testing for multiple sterile drug products, including Mupirocin Nasal Irrigation, Tobramycin (Bladder) Irrigation, and Verapamil Injectable. No SOP for these tests exists, and non-sterile components were used without subsequent sterilization for some products. This is a recurrent observation for endotoxin testing. * **Environmental Control & Monitoring:** * Verification studies for depyrogenation equipment were scientifically unjustified (e.g., not conducted under current conditions, lacked NIST traceable thermometer, insufficient runs, no endotoxin challenge vials). * Environmental monitoring during media fills showed positive growth, but CFU counts were not documented to confirm compliance with action levels. * Non-viable particulate monitoring during sterile drug production was not performed as per SOP. * Non-sterile towels were used for cleaning ISO-5 hood areas (recurrent observation). * **Personnel Gowning:** The gowning SOP does not require sterile gowns for sterile compounding in the ISO 5 area (recurrent observation). * **Quality Control Unit Deficiencies:** The Pharmacist-in-charge failed to review cleanroom testing and certification reports, as required by the Quality Assurance Program SOP (