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FDA Inspection
•Biomat USA, Inc.•June 15, 2012

Biomat USA, Inc. – FDA Inspection, Jun 15, 2012

Record Details

This FDA Inspection record concerns Biomat USA, Inc., with an inspection on June 15, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Biomat USA, Inc.
Inspection Date
June 15, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · a4434d93-9fcc-49da-b3aa-ed7b2e01cf3d

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
786511
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

1
  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.

3
DateClassificationOfficeProject area
September 21, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 27, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 14, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Biomat USA, Inc.
  • FDA Inspection 1069022 - 2018-09-21
  • FDA Inspection 959868 - 2016-01-27
  • FDA Inspection 878532 - 2014-05-14

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