Mylan Specialty, L.P., Morgantown, WV – FDA Inspections

Inspection records and compliance data for Mylan Specialty, L.P. in Morgantown, West Virginia. 9 FDA inspections on record, last inspected May 23, 2013.

Company Profile

This profile covers Mylan Specialty, L.P. based in Morgantown, West Virginia, United States.

FDA Inspection History

FDA inspections: 9
OAI: 0
VAI: 2
NAI: 7
Form 483s: 0
Warning letters: 0

First inspected July 8, 2009. Last inspected May 23, 2013.

Most cited issue areas

Complaint Handling Procedure1 inspection
Procedures to be written and followed1 inspection
Second person sign off1 inspection

FDA inspections (9)

Date	Result	FDA center(s)	Insp. #
May 23, 2013	VAI	Human Drugs · Drug Quality Assurance	833616
April 22, 2013	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	828428
February 16, 2012	NAI	Human Drugs · Drug Quality Assurance	770930
February 25, 2011	NAI	Medical Devices & Rad Health · Compliance: Devices	711403
January 14, 2011	VAI	Human Drugs · Drug Quality Assurance	707604
May 11, 2010	NAI	Human Drugs · Drug Quality Assurance	662822
September 17, 2009	NAI	Medical Devices & Rad Health · Compliance: Devices	620092
July 8, 2009	NAI	Human Drugs · Bioresearch Monitoring	596139
July 8, 2009	NAI	Human Drugs · Drug Quality Assurance	596129

FDA documents

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

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