FDA Inspection 1047769 — West Coast Laboratories, Inc.
The FDA completed an inspection of West Coast Laboratories, Inc. on April 11, 2018 in Gardena, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gardena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15725 | 21 CFR 111.365(g) | Identifying, holding - contamination, mix-ups |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 16016 | 21 CFR 111.140(b)(2)(ii) | Signature; review, approval, rejection; reprocessing |
| 16017 | 21 CFR 111.140(b)(3) | Records - material review, disposition documentation |