FDA Inspection 879745 — Vitalab Company, Inc
The FDA completed an inspection of Vitalab Company, Inc on May 15, 2014 in Liberty, MO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 15, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Liberty, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15508 | 21 CFR 111.27(a)(5)(ii) | Refrigerator, freezer - alarm |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15574 | 21 CFR 111.153 | Written procedures - rejected components, packaging, labels |
| 15722 | 21 CFR 111.365(j) | Containers - segregating, identifying |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |