FDA Inspection 774909 — GMP Laboratories of America Inc
The FDA completed an inspection of GMP Laboratories of America Inc on March 29, 2012 in Anaheim, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2012
- Fiscal Year
- 2012
- 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 |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15803 | 21 CFR 111.560(c) | Product complaint -investigate, findings, follow-up |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |