FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Nov 20, 2017
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on November 20, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b005e9ca-ed56-4789-91d2-4b7820d4912f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031702
- 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
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Other FDA inspections of Biomat USA Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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