FDA Inspection 697740 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on Nov 10, 2010 in Farmington Hills, MI. 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)
- End Date
- Nov 10, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Farmington Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |