FDA Inspection 1256873 — Advanced Nutriceuticals, LLC
The FDA completed an inspection of Advanced Nutriceuticals, LLC on Nov 22, 2024 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 22, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18959 | FDCA 501(a)(2)(A) | Location, ISO 5 classified area |
| 22731 | FDCA 501(a)(2)(A) | Vermin, production area/adjacent areas |
| 22732 | FDCA 501(a)(2)(A) | Contamination, production area/adjacent areas |
| 22742 | FDCA 501(a)(2)(A) | Exposed to lower quality air/ISO 5 |
| 22743 | FDCA 501(a)(2)(A) | Personnel moving quickly, disrupting unidirectional airflow |
| 22749 | FDCA 501(a)(2)(A) | Production areas, difficult to clean/particle generating |
| 22758 | FDCA 501(a)(2)(A) | Non-sterile disinfecting agents, ISO 5 area/classified areas |
| 22759 | FDCA 501(a)(2)(A) | Sporicidal agent, ISO 5/classified areas |
| 22761 | FDCA 501(a)(2)(A) | Lack of disinfection, equipment/supplies from lower to higher quality air |
| 22769 | FDCA 501(a)(2)(A) | Media fills, failure |