FDA Inspection 1136642 — Hampshire Labs, Inc.
The FDA completed an inspection of Hampshire Labs, Inc. on March 15, 2021 in Minneapolis, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15813 | 21 CFR 111.570(b)(2)(ii)(B) | Record - product complaint; batch, lot, control number |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |