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FDA Inspection
•Champion Medical, LLC•September 27, 2010

Champion Medical, LLC – FDA Inspection, Sep 27, 2010

Record Details

This FDA Inspection record concerns Champion Medical, LLC, with an inspection on September 27, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Champion Medical, LLC
Inspection Date
September 27, 2010
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · d8c40fa2-9543-4735-baa0-8df9c7dfbcbf

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
682177
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

3
  1. 21 CFR 1271.160(a)All core requirements covered in program
  2. 21 CFR 1271.265(f)Return to inventory--procedures
  3. 21 CFR 1271.160(b)(2)Procedures for complaints and other information

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Champion Medical, LLC

1
DateClassificationOfficeProject area
December 18, 2013VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Champion Medical, LLC
  • FDA Inspection 859338 - 2013-12-18

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