FDA 483 - Stonegate Pharmacy LP - March 02, 2016

This FDA Form 483 documents observations from an inspection, identifying multiple deficiencies in the facility's operations related to sterile drug product manufacturing.

**Key Observations:**

* **Sterilization Process Validation:** Procedures for preventing microbiological contamination lack adequate validation of the sterilization process. * **Media Fills:** Media fills do not accurately simulate actual production or worst-case conditions, failing to cover all operators involved in preparing injectable drug products. * **Environmental Monitoring:** Aseptic processing areas have deficient systems for monitoring environmental conditions. * **Disinfection Practices:** Non-sterile wipes are used for disinfecting the ISO 5 laminar flow hood (LFH). * **Personnel Gowning:** Personnel clothing is inappropriate for duties performed in drug product manufacturing. * **Discrepancy Investigations:** Unexplained discrepancies and batch failures are not thoroughly reviewed, even if the batch has been distributed. * **Container Closure Systems:** Container closure systems do not adequately protect against foreseeable external factors causing deterioration or contamination. * **Container/Closure Sterilization:** Drug product containers and closures are not sterilized or processed to remove pyrogenic properties. * **Sterility/Pyrogen Testing:** Each batch of sterile, pyrogen-free drug product is not laboratory tested for conformance to these requirements. * **Stability Testing:** No written program exists to assess drug product stability characteristics. * **Equipment Cleaning/Maintenance:** Written procedures for cleaning and