FDA 483 - Rx Unlimited Pharmacy - October 21, 2022

An FDA inspection of Rx Unlimited Pharmacy in North Hills, CA, a producer of nonsterile and sterile drug products, revealed significant deficiencies. Observations included inadequate cleaning to prevent cross-contamination of hazardous drugs, use of non-pharmaceutical grade components without proper testing, improper gowning procedures, and pest activity in production-adjacent areas. These issues indicate a lack of control over manufacturing processes and environmental conditions, posing potential risks to drug product quality and patient safety.