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

Source: https://www.keypedia.com/records/483/advanced-nutraceuticals-llc/cceeaa69-f086-497f-84d9-5530f6ab5621

> FDA 483 for Advanced Nutraceuticals, LLC on November 22, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Nutraceuticals, LLC
- Inspection Date: 2024-11-22
- Product Type: Drugs
- Summary: 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

## Related Documents

- [483 - 2020-10-29](https://www.keypedia.com/records/483/advanced-nutraceuticals-llc/34df47c1-7221-47c6-b959-5eedcde51c00)
- [483 - 2024-11-22](https://www.keypedia.com/records/483/advanced-nutraceuticals-llc/c636e737-9bd7-47d4-a95f-d1f1d13a33da)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/advanced-nutraceuticals-llc/267c4adb-b314-4cd9-9f90-9047f8ad90d2