FDA 483 - Advanced Nutraceuticals, LLC - November 22, 2024

The FDA Form 483 details multiple objectionable conditions observed during an inspection.

**Facility and Operations:** The facility compounds sterile and non-sterile drugs, including hazardous drugs, with technicians preparing numerous IV bags daily. Sterile processing involves transferring media from vial sets into sterile vials.

**Violations and Observations:** 1. **Inadequate Media Fills:** Media fills do not simulate worst-case aseptic processing conditions. The current media fill simulates a single IV bag, while technicians produce up to 600 IV bags daily, with a maximum of 1,600, mixing up to 11 vials per bag. 2. **ISO 5 Area Location:** The ISO 5 Laminar Airflow Hood (LAFH) is located within an unclassified room. 3. **Vermin Presence:** Dead mosquitoes and other insects were found on the exhaust layer of Biological Safety Cabinets (BSCs) in the segregated hazardous drug facility. A live spider was observed in the non-sterile hazardous drug compounding room. 4. **Infrequent Sporicidal Use:** Sporicidal agent use in the facility was infrequent. 5. **Contamination:** Yellow stain spots were observed inside the HEPA filter of the ISO 5 LAFH after cleaning. A cart used for supply storage next to the ISO 5 LAFH was visibly dirty after cleaning and remained dirty during IV bag preparation. 6. **Lack of Disinfection:** Techn