FDA Inspection 850294 — GMP Laboratories Of America Inc
The FDA completed an inspection of GMP Laboratories Of America Inc on Sep 25, 2013 in Anaheim, 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). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |