FDA Inspection 774909 — GMP Laboratories Of America Inc
The FDA completed an inspection of GMP Laboratories Of America Inc on Mar 29, 2012 in Anaheim, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 29, 2012
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- 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 |