FDA Inspection 999080 — Grifols Bio Supplies Inc
The FDA completed an inspection of Grifols Bio Supplies Inc on Oct 14, 2016 in Miami, FL. 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
- Oct 14, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18068 | 21 CFR 630.5(d) | CPR certification |
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |