Mylan Pharmaceuticals ULC — FDA Facility Profile

FEI 3002807060

Mylan Pharmaceuticals ULC is an FDA-inspected facility (FEI 3002807060) located in Etobicoke, CA. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Oct 31, 2014: No Action Indicated (NAI)
Inspections on record
3 (3 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
Recalls as the recalling firm
1, latest Apr 4, 2005
Import refusals
10 or more

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
Oct 31, 2014No Action Indicated (NAI)No citations listed
Jul 11, 2012No Action Indicated (NAI)No citations listed
Feb 26, 2009No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Apr 4, 2005Class IIID-211-5FLUCONAZOLE TABLETS, 100 mg, 100 count unit dose package, 10 Blister Strips of 10 tablets…
Misbranding; partially illegible print on blister strips

Facility details

Company
Mylan Pharmaceuticals ULC
Location
Etobicoke (CA)
Source
inspections

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