FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Apr 21, 2011
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on April 21, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- April 21, 2011
- Product Type
- Biologics
View Company Profile
ID · 79af57fc-a731-4743-afdf-50d8de981dbf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 720538
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.65(b)(2)(i)Physician review of results
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 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 |
|---|---|---|---|
| March 28, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 19, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 19, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 28, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1089646 - 2019-03-28
- FDA Inspection 1052043 - 2018-03-19
- FDA Inspection 985194 - 2016-07-19
- FDA Inspection 898357 - 2014-09-28
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