FDA 483 - SterRx, LLC - November 04, 2021

This FDA Form 483 documents observations from an inspection, highlighting multiple deficiencies in the facility's operations and quality systems.

**Facility and Operations:** The aseptic processing areas are deficient, lacking proper HEPA-filtered air supply under positive pressure. Specifically, the IV Bag filling line (Equipment # (b) (4)) and its enclosure do not provide first-pass HEPA-filtered laminar flow air over all critical ISO 5 classified areas.

**Violations and Observations:** * **Environmental Control:** Inadequate air supply and a deficient system for monitoring environmental conditions in aseptic processing areas. * **Equipment Design & Maintenance:** Equipment is not appropriately designed for cleaning and maintenance. Lubricants and coolants contact components/closures, potentially altering drug product safety, identity, strength, quality, or purity. Procedures for cleaning and maintenance are deficient in protecting clean equipment from contamination. * **Container Closure:** Container closure systems do not adequately protect against foreseeable external factors. * **Aseptic Processing Validation:** Procedures to prevent microbiological contamination lack adequate validation of the aseptic process. * **Personnel & Training:** Protective apparel is not worn as necessary to prevent contamination. Employees lack adequate training for their specific functions. * **Quality Control & Documentation:** Failure to thoroughly review unexplained discrepancies or batch failures. The written stability program lacks meaningful test methods. Complaint records are deficient, missing known replies to complainants.

**Critical Findings/Deficiencies:** The lack