FDA Inspection 826567 — Prime Health Products
The FDA completed an inspection of Prime Health Products on March 22, 2013 in Etobicoke. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Etobicoke (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15571 | 21 CFR 111.153 | Written procedures - packaging |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |