Warner Chilcott Company LLC, Manati, PR – FDA Inspections

Inspection records and compliance data for Warner Chilcott Company LLC in Manati, Puerto Rico. 3 FDA inspections on record, 1 Form 483, last inspected October 03, 2016.

Company Profile

This profile covers Warner Chilcott Company LLC based in Manati, Puerto Rico, United States.

FDA Inspection History

FDA inspections: 3
OAI: 0
VAI: 1
NAI: 2
Form 483s: 1
Warning letters: 0

First inspected April 5, 2010. Last inspected October 3, 2016.

Most cited issue areas

Cleaning SOPs/schedules1 inspection
Sampling and testing plans not described1 inspection
SOPs not followed / documented1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
October 3, 2016	VAI	Human Drugs · Drug Quality Assurance	988930
October 30, 2014	NAI	Human Drugs · Drug Quality Assurance	903590
April 5, 2010	NAI	Human Drugs · Drug Quality Assurance	655951

FDA documents

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

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