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

An FDA inspection of Advanced Nutriceuticals, LLC, a sterile and non-sterile drug producer in Indianapolis, IN, was conducted from November 13-22, 2024. The inspection, led by Investigator Taichun Qin, identified ten observations.

Key violations include: 1. **Inadequate Media Fills:** Media fills for aseptic production do not simulate worst-case conditions, failing to reflect the actual volume and complexity of daily IV bag production (e.g., simulating one IV bag vs. up to (b)(4) daily). 2. **Unclassified ISO 5 Area:** The ISO 5 Laminar Airflow Hood (LAFH) used for sterile mixing is located within an unclassified room, and its certification (dated 6/4/2024) did not include classification of the IV room, which has been in use since April 2021. 3. **Vermin Presence:** Dead insects were found in Biological Safety Cabinets (BSCs) exhaust layers, and a live spider was observed in the non-sterile hazardous drug compounding room. 4. **Infrequent Sporicidal Agent Use:** Sporicidal agents were not consistently used for cleaning the ISO 5 LAFH, despite environmental sampling (June 11, 2024) identifying fungal and mold growth in the IV room. 5. **Contamination:** Yellow stains were observed inside