FDA Inspection
Biomat USA Inc.Biomat USA Inc. – FDA Inspection, Jul 13, 2018
Record Details
This FDA Inspection record concerns Biomat USA Inc., with an inspection on July 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f4d57389-921f-46ee-a14d-0b657ffeef85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058765
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 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 |
|---|---|---|---|
| June 9, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 26, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 25, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 11, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc.
- FDA Inspection 1172880 - 2022-06-09
- FDA Inspection 885018 - 2014-06-26
- FDA Inspection 751847 - 2011-10-25
- FDA Inspection 633983 - 2009-12-11
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