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Labtician Ophthalmics Inc., Oakville, Canada – FDA Inspections

Inspection records and compliance data for Labtician Ophthalmics Inc. in Oakville. 3 FDA inspections on record, 1 Form 483, last inspected October 12, 2018.

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Company Profile

This profile covers Labtician Ophthalmics Inc. based in Oakville, Canada.

FDA Inspection History

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

First inspected November 5, 2009. Last inspected October 12, 2018.

Most cited issue areas

  • Documentation1 inspection
  • Lack of or inadequate procedures - Acceptance activities1 inspection
  • Procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
October 12, 2018Not classifiedMedical Devices & Rad Health1121248
July 14, 2016NAIMedical Devices & Rad Health · Postmarket Assurance: Devices979474
November 5, 2009VAIMedical Devices & Rad Health · Compliance: Devices635209
FDA documents

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

Other regulators (1)
  • Health Canada · 1 inspection · last February 20, 2019
Related Companies (10)

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ICU Medical Inc.
Ward Photonics, LLC
Rockwell Medical, Inc.
SunMed Holdings, LLC
Visionary Medical Supplies Inc.
Abbott Molecular, Inc.
Hologic, Inc.
Q-Med AB
Company Information

Name

Labtician Ophthalmics Inc.

FEI Number

3002807445

Canada Business Number

121225072

Address

2140 Winston Park Dr Unit 6, Oakville, Canada

Country

Canada

ID: d6b9b2c1-0c4a-4122-adc8-0adc2c9497af

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