FDA Inspection 565006 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on Feb 12, 2009 in Lewiston, ME. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 12, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lewiston, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 368 | 21 CFR 640.72(d) | Donor reaction |