FDA Inspection 789152 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on Jun 15, 2012 in Everett, WA. 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
- Jun 15, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Everett, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 98 | 21 CFR 606.100(c) | Thorough investigations |