FDA Inspection 1165542 — Biotest, LLC
The FDA completed an inspection of Biotest, LLC on March 25, 2022 in Colorado Springs, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 25, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |