FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Apr 24, 2018
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on April 24, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f02962e7-eb88-4794-b66a-357a628d8fe2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049621
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 640.65(b)(3)Donor identification
- 21 CFR 640.64(e)Prevention of contamination
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 21, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 2, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 13, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1179250 - 2022-08-29
- FDA Inspection 953240 - 2015-12-21
- FDA Inspection 838107 - 2013-07-02
- FDA Inspection 717043 - 2011-04-13
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