FDA Inspection
Biomat USA Inc.Biomat USA Inc. – FDA Inspection, Jun 21, 2011
Record Details
This FDA Inspection record concerns Biomat USA Inc., with an inspection on June 21, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc.
- Inspection Date
- June 21, 2011
- Product Type
- Biologics
View Company Profile
ID · f84565f0-8934-469b-9898-175aa321897f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730999
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.3(c)(2)History of viral hepatitis - close contact
- 21 CFR 610.41Donor Deferral
- 21 CFR 630.40(b)(1)Deferred or not eligible
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Other FDA inspections of Biomat USA Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 24, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc.
- FDA Inspection 1243015 - 2024-06-28
- FDA Inspection 1063223 - 2018-08-24
- FDA Inspection 935765 - 2015-07-20
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