FDA Inspection 859603 — Brisas Del Caribe Corp
The FDA completed an inspection of Brisas Del Caribe Corp on Dec 19, 2013 in Canovanas, PR. 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
- Dec 19, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Canovanas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |