FDA Inspection 1115118 — GMP Laboratories of America Inc
The FDA completed an inspection of GMP Laboratories of America Inc on January 14, 2020 in Anaheim, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 14, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |