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FDA Inspection
•Biomet West, Inc.•March 29, 2016

Biomet West, Inc. – FDA Inspection, Mar 29, 2016

Record Details

This FDA Inspection record concerns Biomet West, Inc., with an inspection on March 29, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Biomet West, Inc.
Inspection Date
March 29, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 2850463f-3225-447a-af38-446b0ddd85ae

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
975480
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

2
  1. 21 CFR 1271.195(d)Documentation not maintained
  2. 21 CFR 1271.195(b)Periodic inspection

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Biomet West, Inc.

2
DateClassificationOfficeProject area
November 29, 2018NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 12, 2013VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Biomet West, Inc.
  • FDA Inspection 1078429 - 2018-11-29
  • FDA Inspection 827062 - 2013-04-12

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