FDA Inspection 1169512 — GCP Laboratories
The FDA completed an inspection of GCP Laboratories on May 13, 2022 in Gulfport, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 13, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gulfport, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1409 | 21 CFR 211.42(c)(4) | In-Process Material Area |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |