FDA 483 - Central Admixture Pharmacy Services, Inc. - January 21, 2016

This FDA Form 483 document outlines several significant observations made during an inspection, indicating deficiencies in the facility's manufacturing and quality control processes for drug products, particularly those purporting to be sterile.

Key observations include: 1. **Equipment and Utensil Maintenance:** Equipment and utensils are not maintained at appropriate intervals, which could lead to contamination affecting the safety, identity, strength, quality, or purity of the drug product. 2. **Sterilization Process Validation:** Procedures designed to prevent microbiological contamination of sterile drug products lack adequate validation of the sterilization process. This is a critical deficiency for sterile manufacturing. 3. **Product Release Testing:** The testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications prior to release, raising concerns about product quality and safety reaching the market. 4. **Personnel Clothing:** The clothing worn by personnel engaged in processing drug products is not appropriate for their duties, which could compromise product integrity, especially in aseptic environments. 5. **Aseptic Area Cleaning:** Aseptic processing areas are deficient concerning the system for cleaning and disinfecting the room to produce aseptic conditions, directly impacting the sterility assurance of the products manufactured.

These observations collectively point to significant issues within the facility's quality system, manufacturing controls, and aseptic processing practices, indicating potential risks to drug product quality, safety, and efficacy.