FDA Inspection 1145666 — Caribe Holdings (Cayman) Co. Ltd
The FDA completed an inspection of Caribe Holdings (Cayman) Co. Ltd on July 2, 2021 in Dorado, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dorado, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |