FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, May 10, 2011
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on May 10, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- May 10, 2011
- Product Type
- Biologics
View Company Profile
ID · 11440abf-3d86-4884-83f5-eb38a4d21ea5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 726568
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(b)Required records
- 21 CFR 630.40(a)Notification
- 21 CFR 606.171Biological product deviation report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 26, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1023216 - 2017-08-14
- FDA Inspection 820154 - 2013-02-26
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