FDA Inspection 1115118 — GMP Laboratories Of America Inc
The FDA completed an inspection of GMP Laboratories Of America Inc on Jan 14, 2020 in Anaheim, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 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 |