FDA Inspection 823637 — Providence VA Healthcare System
The FDA completed an inspection of Providence VA Healthcare System on Feb 28, 2013 in Providence, RI. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 28, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Providence, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |