FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Mar 3, 2011
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on March 3, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- March 3, 2011
- Product Type
- Biologics
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ID · 8c84b451-16ea-47bf-ab23-44a958d7927b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 714404
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 15, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 9, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 12, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1174876 - 2022-06-29
- FDA Inspection 935614 - 2015-07-15
- FDA Inspection 832423 - 2013-05-09
- FDA Inspection 565006 - 2009-02-12
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