639684
GMP Laboratories of America Inc — FEI 3002710875
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 |