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Element Materials Technology Canada Inc., Mississauga, Canada – FDA Inspections

Inspection records and compliance data for Element Materials Technology Canada Inc. in Mississauga. 6 FDA inspections on record, 2 Form 483s, last inspected January 22, 2025.

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Company Profile

This profile covers Element Materials Technology Canada Inc. based in Mississauga, Canada.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
4
NAI
1
Unclassified
1
Form 483s
2
Warning letters
0

First inspected July 29, 2009. Last inspected January 22, 2025.

Most cited issue areas

  • Authority lacking to review records, investigate errors1 inspection
  • Procedures not in writing, fully followed1 inspection
  • Second person sign off1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
January 22, 2025Not classifiedHuman Drugs1258899
October 18, 2019VAIHuman Drugs · Drug Quality Assurance1106890
September 15, 2017VAIHuman Drugs · Drug Quality Assurance1027543
February 9, 2015VAIHuman Drugs · Drug Quality Assurance918934
December 6, 2012VAIHuman Drugs · Drug Quality Assurance812738
July 29, 2009NAIHuman Drugs · Drug Quality Assurance610534
FDA documents

Form 483s (2)

  • Form 483s · October 18, 2019
  • Form 483s · September 20, 2019
Other regulators (1)
  • Health Canada · 3 inspections · last June 12, 2024
People (2)
Unnee Ranjan
Person
Edmund F. Mrak
Person
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Company Information

Name

Element Materials Technology Canada Inc.

FEI Number

3002807812

Canada Business Number

881290324

Address

2399 Speakman Dr Suite 200 & 210, Mississauga, Canada

Country

Canada

ID: c806fa60-ad44-4fcb-8287-fcb954bcbcf4

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