Sanofi-Aventis US LLC, Saint Louis, MO – FDA Inspections

Inspection records and compliance data for Sanofi-Aventis US LLC in Saint Louis, Missouri. 5 FDA inspections on record, 1 Form 483, last inspected June 02, 2017.

Company Profile

This profile covers Sanofi-Aventis US LLC based in Saint Louis, Missouri, United States.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 1
NAI: 3
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected January 28, 2009. Last inspected June 2, 2017.

Most cited issue areas

Changes to Procedures Not Reviewed, Approved1 inspection
Distribution of oldest stock first1 inspection
Extent of discrepancy, failure investigations1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
June 2, 2017	Not classified	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	1012790
February 12, 2014	NAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	867881
March 14, 2012	VAI	Human Drugs · Drug Quality Assurance	772113
October 6, 2010	NAI	Human Drugs · Drug Quality Assurance	684201
January 28, 2009	NAI	Human Drugs · Drug Quality Assurance	563141

FDA documents

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

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