FDA Inspection 749989 — Ancient Naturals LLC
The FDA completed an inspection of Ancient Naturals LLC on October 14, 2011 in Lake Mary, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 14, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Lake Mary, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |