FDA Inspection 720538 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on April 21, 2011 in Waukegan, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 21, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Waukegan, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9314 | 21 CFR 640.65(b)(2)(i) | Physician review of results |