FDA Inspection 639684 — GMP Laboratories of America Inc
The FDA completed an inspection of GMP Laboratories of America Inc on January 20, 2010 in Anaheim, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 15431 | 21 CFR 111.15(e)(1) | Water supply - not component - suitability |
| 15452 | 21 CFR 111.15(f)(5) | Plumbing - backflow, cross connection |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4322 | 21 CFR 211.101(d) | Component release checked by 2nd person |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 4576 | 21 CFR 211.192 | No written record of investigation |