FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on December 1, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- December 1, 2011
- Product Type
- Biologics
View Company Profile
ID · 812227a7-323f-421e-b972-03734da85af4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755174
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 640.63(d)Unreliable answers
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 7, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 31, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 5, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 17, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1220636 - 2023-08-25
- FDA Inspection 1028286 - 2017-09-07
- FDA Inspection 939664 - 2015-07-31
- FDA Inspection 865384 - 2014-02-05
- FDA Inspection 702525 - 2010-12-17
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