FDA Inspection 653099 — Biovation Labs
The FDA completed an inspection of Biovation Labs on March 22, 2010 in West Valley City, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 22, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- West Valley City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15562 | 21 CFR 111.260(l)(1) | Batch record - quality control review; production |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15768 | 21 CFR 111.420(c) | Repackaged, relabeled - quality control: approve, rejects |
| 15868 | 21 CFR 111.75(b)(2) | Specifications met - deviation, unanticipated occurrence |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15972 | 21 CFR 111.120(b) | Quality control operations - specifications; components, packaging, labels |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 15999 | 21 CFR 111.127(h) | Quality control operations - packaging, labeling; approving, rejecting |