FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Dec 28, 2010
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on December 28, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- December 28, 2010
- Product Type
- Biologics
View Company Profile
ID · 7da8354b-0dde-4e8d-81d0-9d9970e54886
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 703347
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.65(b)(2)(i)Physician review of four month sample
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 9, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 22, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 6, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1034809 - 2017-10-30
- FDA Inspection 945282 - 2015-10-09
- FDA Inspection 858689 - 2013-12-13
- FDA Inspection 787786 - 2012-06-22
- FDA Inspection 567091 - 2009-03-06
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