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Ensign Laboratories Proprietary Ltd, Mulgrave, Australia – FDA Inspections

Inspection records and compliance data for Ensign Laboratories Proprietary Ltd in Mulgrave. 1 FDA inspection on record, last inspected July 15, 2022.

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Company Profile

This profile covers Ensign Laboratories Proprietary Ltd based in Mulgrave, Australia.

FDA Inspection History

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

Inspected July 15, 2022.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Calibration/Inspection/Checking not done1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
July 15, 2022VAIHuman Drugs · Drug Quality Assurance1175015
FDA documents

Form 483s (1)

  • Form 483s · July 15, 2022
People (1)
Erik W. Koester
Person
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Company Information

Name

Ensign Laboratories Proprietary Ltd

FEI Number

3003380641

Address

490-500 Wellington Rd, Mulgrave, Australia

Country

Australia

ID: a2609ae9-a810-4910-9ed6-71221b04abb7

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