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Sterimax, Inc., Oakville, Canada – FDA Inspections

Inspection records and compliance data for Sterimax, Inc. in Oakville. 2 FDA inspections on record, last inspected March 06, 2020.

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Company Profile

This profile covers Sterimax, Inc. based in Oakville, Canada.

FDA Inspection History

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

First inspected December 7, 2018. Last inspected March 6, 2020.

Most cited issue areas

  • Backup data not assured as exact and complete1 inspection
  • Computer control of master formula records1 inspection
  • Equipment Design, Size and Location1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
March 6, 2020VAIHuman Drugs · Drug Quality Assurance1119942
December 7, 2018Not classifiedHuman Drugs1076623
FDA documents

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

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Hani Alasaad, MBBS, DABIM, FRCPC, FACP, FACE
Uma Athale, M.D., Clinical Investigator
Brian Feagan
Kevin Song, MD
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JEAN BERGERON
Company Information

Name

Sterimax, Inc.

FEI Number

3011394370

Canada Business Number

866983265RC0002

Address

2770 Portland Dr, Oakville, Canada

Country

Canada

ID: dc07ffc4-3253-4276-990c-25754cabf0a6

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