FDA Inspection 730999 — Biomat USA Inc.
The FDA completed an inspection of Biomat USA Inc. on Jun 21, 2011 in Chicago, IL. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 21, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 218 | 21 CFR 640.3(c)(2) | History of viral hepatitis - close contact |
| 9236 | 21 CFR 630.40(b)(1) | Deferred or not eligible |
| 9256 | 21 CFR 610.41 | Donor Deferral |