FDA Inspection 606686 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on Jul 17, 2009 in Gary, IN. 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
- Jul 17, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gary, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |