FDA 483 - UCSF Home Therapy Services - September 12, 2014

This FDA Form 483 document details observations made during an inspection, indicating several deficiencies in the facility's operations related to sterile drug product manufacturing.

**Key Observations:**

* **Sterilization Process Validation:** Procedures intended to prevent microbiological contamination of sterile drug products lack adequate validation of the sterilization process. * **Batch Testing for Sterility/Pyrogenicity:** Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to confirm conformance to these requirements. * **Environmental Monitoring in Aseptic Areas:** The system for monitoring environmental conditions in aseptic processing areas is deficient. * **Cleaning and Disinfection in Aseptic Areas:** The system for cleaning and disinfecting rooms and equipment to achieve aseptic conditions in aseptic processing areas is deficient. * **Absence of Written Procedures for Production and Process Controls:** There are no written procedures for production and process controls designed to ensure that drug products possess the identity, strength, quality, and purity they claim or are represented to have.

These observations highlight significant issues with the facility's quality system, particularly concerning aseptic processing, sterility assurance, and overall manufacturing controls, indicating potential risks to drug product quality and patient safety.