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Apotex Fermentation Inc. — FDA Facility Profile

FEI 3000043315

Apotex Fermentation Inc. is an FDA-inspected facility (FEI 3000043315) located in Winnipeg, CA. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 22, 2019: Voluntary Action Indicated (VAI)
Inspections on record
4 (3 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 22, 2019Voluntary Action Indicated (VAI)No citations listed
Oct 31, 2014No Action Indicated (NAI)No citations listed
Jun 7, 2012Voluntary Action Indicated (VAI)No citations listed
Mar 12, 2010Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Apotex Fermentation Inc.
Location
Winnipeg (CA)
Source
inspections

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.