FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Apr 21, 2009
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on April 21, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- April 21, 2009
- Product Type
- Biologics
View Company Profile
ID · d0326678-bffe-46c6-91f4-bd4b51f9c5e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 576969
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 640.76(c)Source Plasma - Re-labeling
- 21 CFR 640.63(c)(10)Narcotics use
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 640.72(a)(1)Shipping temperature requirements
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 610.46(a)(1)Quarantine and notification
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 20, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 17, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 20, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1049586 - 2018-02-15
- FDA Inspection 985568 - 2016-05-20
- FDA Inspection 896180 - 2014-09-17
- FDA Inspection 746815 - 2011-09-20
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