FDA Inspection 914902 — Biovation Labs
The FDA completed an inspection of Biovation Labs on March 2, 2015 in West Valley City, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 2, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- West Valley City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15391 | 21 CFR 111.10(b)(3) | Hand washing |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |