FDA Inspection 825388 — Hampshire Labs, Inc.
The FDA completed an inspection of Hampshire Labs, Inc. on April 4, 2013 in Minneapolis, MN. 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
- April 4, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15920 | 21 CFR 111.95(b)(1) | Records - established specifications |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |