FDA Inspection 850294 — GMP Laboratories of America Inc
The FDA completed an inspection of GMP Laboratories of America Inc on September 25, 2013 in Anaheim, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 15459 | 21 CFR 111.20(d) | Physical plant - design and construction |
| 15473 | 21 CFR 111.20(c)(7) | Physical plant - separate areas - holding |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |