FDA Inspection 923234 — West Coast Laboratories, Inc.
The FDA completed an inspection of West Coast Laboratories, Inc. on March 19, 2015 in Gardena, CA. 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
- March 19, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gardena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15696 | 21 CFR 111.315(e) | Examination, testing; established criteria |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |