FDA Inspection 867898 — West Coast Laboratories, Inc.
The FDA completed an inspection of West Coast Laboratories, Inc. on February 18, 2014 in Gardena, CA. 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
- February 18, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gardena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15710 | 21 CFR 111.325(b)(2)(i) | Document; laboratory methodology followed |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15945 | 21 CFR 111.105(i) | QC - required operations packaging/labeling operations |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |