Mylan Pharmaceuticals Inc. — FDA Facility Profile

FEI 3007886374

Mylan Pharmaceuticals Inc. is an FDA-inspected facility (FEI 3007886374) located in San Carlos, CA, US. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 22, 2020: No Action Indicated (NAI)
Inspections on record
5 (1 VAI, 4 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
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
Sep 22, 2020No Action Indicated (NAI)No citations listed
Oct 14, 2016No Action Indicated (NAI)No citations listed
Jul 17, 2015Voluntary Action Indicated (VAI)Stability sample storage conditions described (21 CFR 211.166(a)(2))
Testing in same container - closure system (21 CFR 211.166(a)(4))
Establishment of calibration procedures (21 CFR 211.160(b)(4))
Reserve samples identified, representative, stored (21 CFR 211.170(b))
and 1 more
Sep 4, 2014No Action Indicated (NAI)No citations listed
Sep 27, 2012No Action Indicated (NAI)No citations listed

Facility details

Company
Mylan Pharmaceuticals Inc.
Location
San Carlos, CA (US)
Source
inspections

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