FDA Inspection 797098 — VA Caribbean Healthcare System
The FDA completed an inspection of VA Caribbean Healthcare System on Aug 29, 2012 in San Juan, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 47 | 21 CFR 606.40(a)(7) | Provide space for collection, processing, testing, dist, etc |