FDA Inspection 1168368 — Peak Nutritional Products, LLC
The FDA completed an inspection of Peak Nutritional Products, LLC on Apr 27, 2022 in Tampa, FL. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 27, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15802 | 21 CFR 111.560(c) | Product complaint - review, investigation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |