FDA Inspection 928262 — Pristine Bay LLC
The FDA completed an inspection of Pristine Bay LLC on May 19, 2015 in West Chester, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 19, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- West Chester, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |