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•United States

Mylan Pharmaceuticals Inc., San Carlos, CA – FDA Inspections

Inspection records and compliance data for Mylan Pharmaceuticals Inc. in San Carlos, California. 6 FDA inspections on record, 1 Form 483, last inspected September 22, 2020.

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Company Profile

This profile covers Mylan Pharmaceuticals Inc. based in San Carlos, California, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
2
NAI
4
Form 483s
1
Warning letters
0

First inspected September 27, 2012. Last inspected September 22, 2020.

Most cited issue areas

  • Establishment of calibration procedures1 inspection
  • Labeling control records including specimens or copies1 inspection
  • Reserve samples identified, representative, stored1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
September 22, 2020NAIHuman Drugs · Drug Quality Assurance1132054
November 9, 2017VAIHuman Drugs · New Drug Evaluation1031174
October 14, 2016NAIMedical Devices & Rad Health · Compliance: Devices990174
July 17, 2015VAIHuman Drugs · Drug Quality Assurance937344
September 4, 2014NAIHuman Drugs · Drug Quality Assurance894744
September 27, 2012NAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance799168
FDA documents

Form 483s (1)

  • Form 483s · January 7, 2016

EIRs (1)

  • EIRs · November 9, 2018

Other FDA documents (1)

  • Other FDA documents
People (5)
Shane Shupe, Senior Manager, Regulatory Affairs
Person
Massoud Motamed
Person
Pratik S. Upadhyay
Person
Srinivas R. Chennamaneni
Person
Xiaohan Cai
Person
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Company Information

Name

Mylan Pharmaceuticals Inc.

FEI Number

3007886374

Address

150 Industrial Rd, San Carlos, California 94070, United States

Country

United States

ID: 544e75ba-feb1-4947-b3da-4883556581f1

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