FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Mar 9, 2012
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on March 9, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- March 9, 2012
- Product Type
- Biologics
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ID · 32c13d15-ccc3-4aa4-9deb-6b125c461755
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772821
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1027701 - 2017-08-15
- FDA Inspection 938990 - 2015-08-20
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