FDA Inspection 949585 — A.M.S. Biotek, LLC
The FDA completed an inspection of A.M.S. Biotek, LLC on October 16, 2015 in Birmingham, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 16, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Birmingham, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |