FDA Inspection
Biomat USA, IncBiomat USA, Inc – FDA Inspection, Mar 8, 2018
Record Details
This FDA Inspection record concerns Biomat USA, Inc, with an inspection on March 8, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 1a28d544-e305-4769-895e-cc843acf5277
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043565
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 630.10(b)Educational Material
- 21 CFR 606.160(a)(1)Concurrent documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 4, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 17, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 12, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 4, 2008 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA, Inc
- FDA Inspection 1204323 - 2023-04-21
- FDA Inspection 928923 - 2015-06-04
- FDA Inspection 859191 - 2013-12-17
- FDA Inspection 756113 - 2011-12-12
- FDA Inspection 550550 - 2008-12-04
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