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Omega Laboratories Ltd., Montreal, Canada – FDA Inspections

Inspection records and compliance data for Omega Laboratories Ltd. in Montreal. 2 FDA inspections on record, 1 Form 483, last inspected January 17, 2024.

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Company Profile

This profile covers Omega Laboratories Ltd. based in Montreal, Canada.

FDA Inspection History

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

First inspected June 18, 2019. Last inspected January 17, 2024.

Most cited issue areas

  • Calibration/Inspection/Checking not done1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Computer control of master formula records1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
January 17, 2024VAIHuman Drugs · Drug Quality Assurance1227777
June 18, 2019VAIHuman Drugs · Generic Drug Evaluation1094223
FDA documents

Form 483s (1)

  • Form 483s · January 17, 2024
Other regulators (1)
  • Health Canada · 21 inspections · last May 20, 2025
People (1)
Edmund F. Mrak
Person
Related Companies (10)

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Pharmascience Inc.
Apotex Inc.
Sterinova Inc
Alk-Abello Inc.
Ferring Inc.
Taro Pharmaceuticals Inc.
ALBERTA VETERINARY LABORATORES LTD
Halo Pharmaceutical Canada Inc
Company Information

Name

Omega Laboratories Ltd.

FEI Number

3004153143

Address

11177 Hamon St, Montreal, Canada

Country

Canada

ID: 79ded706-b117-405b-bd4c-4d672692c341

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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