FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Jun 21, 2011
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on June 21, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA, Inc
- Inspection Date
- June 21, 2011
- Product Type
- Biologics
View Company Profile
ID · 4ec6bb65-faa5-4b9c-a39c-68057e232967
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 731445
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 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
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 14, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 27, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1225670 - 2023-12-13
- FDA Inspection 1019092 - 2017-07-14
- FDA Inspection 894511 - 2014-08-27
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