Sun Pharmaceutical Industries, LTD., Wixom, MI – FDA Inspections

Inspection records and compliance data for Sun Pharmaceutical Industries, LTD. in Wixom, Michigan. 8 FDA inspections on record (3 OAI), last inspected January 21, 2014.

Company Profile

This profile covers Sun Pharmaceutical Industries, LTD. based in Wixom, Michigan, United States.

FDA Inspection History

FDA inspections: 8
OAI: 3
VAI: 2
NAI: 3
Form 483s: 0
Warning letters: 0

First inspected April 9, 2009. Last inspected January 21, 2014.

Most cited issue areas

Equipment Design, Size and Location2 inspections
Procedures not in writing, fully followed2 inspections
Scientifically sound laboratory controls2 inspections

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
January 21, 2014	NAI	Human Drugs · Drug Quality Assurance	862802
May 30, 2013	OAI	Human Drugs · Drug Quality Assurance	833497
January 11, 2013	VAI	Human Drugs · Drug Quality Assurance	815058
August 3, 2012	VAI	Human Drugs · Drug Quality Assurance	792974
December 14, 2011	OAI	Human Drugs · Drug Quality Assurance	759172
September 26, 2011	NAI	Human Drugs · Bioresearch Monitoring	746953
May 12, 2009	OAI	Human Drugs · Drug Quality Assurance	572444
April 9, 2009	NAI	Human Drugs · Drug Quality Assurance	586501

FDA documents

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

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