FDA Inspection 1068328 — West Coast Laboratories, Inc.
The FDA completed an inspection of West Coast Laboratories, Inc. on Oct 10, 2018 in Gardena, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 10, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gardena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |