FDA Inspection 1022733 — Pacific Health Laboratories, Inc.
The FDA completed an inspection of Pacific Health Laboratories, Inc. on August 24, 2017 in Parsippany, NJ. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 24, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Parsippany, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15958 | 21 CFR 111.113(a)(5) | Quality control returned dietary supplement; material review, disposition |