FDA Inspection
Biomat USA, Inc.Biomat USA, Inc. – FDA Inspection, Jun 15, 2012
Record Details
This FDA Inspection record concerns Biomat USA, Inc., with an inspection on June 15, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc.
- Inspection Date
- June 15, 2012
- Product Type
- Biologics
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ID · 8bcc679f-7b08-405f-91df-940d75b1ce9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789152
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)(21)Donor notification
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Other FDA inspections of Biomat USA, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 30, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 6, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 24, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 29, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc.
- FDA Inspection 1177924 - 2022-08-17
- FDA Inspection 1057030 - 2018-05-30
- FDA Inspection 881284 - 2014-06-06
- FDA Inspection 677941 - 2010-06-24
- FDA Inspection 602283 - 2009-07-29
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