FDA Inspection 983253 — North American Pharmacal, Inc.
The FDA completed an inspection of North American Pharmacal, Inc. on July 26, 2016 in Norwalk, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Norwalk, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |