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FDA Inspection
•Etex Corporation•July 16, 2018

FDA Inspection 1059083 - Etex Corporation - July 16, 2018

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Record Details

This FDA Inspection record concerns Etex Corporation, with an inspection on July 16, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Etex Corporation
Inspection Date
July 16, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
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ID · debb1651-2420-4347-b723-e6491fee989b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1059083
FDA center
Biologics
Project area
Blood and Blood Products

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
August 19, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
February 15, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
September 29, 2010VAICenter for Devices and Radiological HealthCompliance: Devices
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