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

Source: https://www.keypedia.com/records/483/advanced-nutraceuticals-llc/c636e737-9bd7-47d4-a95f-d1f1d13a33da

> FDA 483 for Advanced Nutraceuticals, LLC on November 22, 2024. Product: Devices. 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: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## 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/cceeaa69-f086-497f-84d9-5530f6ab5621)

## 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

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7