FDA Inspection 572502 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on March 27, 2009 in South Bend, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- South Bend, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 255 | 21 CFR 640.31 | Donor eligibility |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |