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•United States

Ellex iScience, Inc., Fremont, CA – FDA Inspections

Inspection records and compliance data for Ellex iScience, Inc. in Fremont, California. 6 FDA inspections on record, 2 Form 483s, last inspected December 07, 2018.

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Company Profile

This profile covers Ellex iScience, Inc. based in Fremont, California, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
1
NAI
2
Unclassified
3
Form 483s
2
Warning letters
0

First inspected August 16, 2010. Last inspected December 7, 2018.

FDA inspections (6)

DateResultFDA center(s)Insp. #
December 7, 2018Not classifiedMedical Devices & Rad Health1094990
June 12, 2018Not classifiedMedical Devices & Rad Health1094978
September 8, 2017Not classifiedMedical Devices & Rad Health1034615
June 25, 2015NAIMedical Devices & Rad Health · Postmarket Assurance: Devices931524
March 27, 2013NAIMedical Devices & Rad Health · Postmarket Assurance: Devices823616
August 16, 2010VAIMedical Devices & Rad Health · Compliance: Devices675218
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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TeraRecon, Inc.
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Acheve Technology Inc
GenMark Diagnostics, Inc.
Coagusense, Inc.
Arash Aryana M.D.
Company Information

Name

Ellex iScience, Inc.

FEI Number

3005641545

Address

41316 Christy St, Fremont, California 94538, United States

Country

United States

ID: 6cfbafeb-cb97-42d7-b825-94e3a63915fb

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