FDA Inspection 1063032 — PI Pharma Inc
The FDA completed an inspection of PI Pharma Inc on August 22, 2018 in Campton, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 22, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Campton, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15973 | 21 CFR 111.120(c) | Quality control operations - material review, disposition decision |