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FDA Inspection
•Etex Corporation•September 29, 2010

FDA Inspection 680526 - Etex Corporation - September 29, 2010

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Record Details

This FDA Inspection record concerns Etex Corporation, with an inspection on September 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company
Etex Corporation
Inspection Date
September 29, 2010
Product Type
Devices
Office
Center for Devices and Radiological Health
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ID · f4c57819-0306-4ea7-af64-5c8c472f03fa

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
680526
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

1
  1. 21 CFR 820.100(b)Documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Etex Corporation

5
DateClassificationOfficeProject area
September 25, 2024Not classifiedNew England District Office
May 23, 2019VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 16, 2018VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 19, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
February 15, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
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