FDA Inspection 956476 — Brisas Del Caribe Corp
The FDA completed an inspection of Brisas Del Caribe Corp on Feb 4, 2016 in Canovanas, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 4, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Canovanas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |