FDA Inspection 717014 — West Coast Laboratories, Inc.
The FDA completed an inspection of West Coast Laboratories, Inc. on March 21, 2011 in Gardena, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gardena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15380 | 21 CFR 111.8 | Written procedures - sick or infected personnel |
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |
| 16074 | 21 CFR 111.35(b)(4) | Records - equipment; calibrations, inspections, checks |