FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Oct 30, 2012
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on October 30, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- October 30, 2012
- Product Type
- Biologics
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ID · 99154883-eb33-43c6-a939-64bfc83ca240
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 807222
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Biomat USA Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 27, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 25, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 4, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1111018 - 2019-10-10
- FDA Inspection 1031049 - 2017-10-27
- FDA Inspection 969079 - 2016-04-25
- FDA Inspection 708599 - 2011-02-04
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