FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Apr 3, 2013
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on April 3, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- April 3, 2013
- Product Type
- Biologics
View Company Profile
ID · d073d09a-00fc-4792-a1e0-571a4eb204fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 825642
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Concurrent documentation
- 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 |
|---|---|---|---|
| April 20, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 16, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 24, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 30, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1050833 - 2018-04-20
- FDA Inspection 985406 - 2016-09-16
- FDA Inspection 731666 - 2011-06-24
- FDA Inspection 578982 - 2009-04-30
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