Sanofi-Aventis U.S. LLC – FDA Warning Letter, May 13, 2010

The FDA issued a Warning Letter to Sanofi-Aventis U.S. LLC following an inspection from April 16 to May 13, 2010, focusing on Postmarketing Adverse Drug Experience (PADE) reporting. The inspection revealed failures to comply with 21 U.S.C. § 355(k) and 21 C.F.R. Sections 314.80 and 314.81, constituting prohibited acts under Section 301(e) of the Act.

Key violations include: - Inadequate written procedures for adverse event surveillance, receipt, evaluation, and reporting (21 CFR 314.80(b)). - Failure to submit serious and unexpected ADE reports within 15 calendar days (21 CFR 314.80(c)(1)(i)), with approximately 185 initial reports and 127 follow-up reports submitted late between January 1, 2009, and March 31, 2010. - Failure to submit follow-up PADE reports within 15 calendar days of new information (21 CFR 314.80(c)(1)(ii)). - Inadequate Standard Operating Procedures (SOPs) lacking clear ADE definitions and work instructions for investigating incomplete reports. - An "Adverse Event Reporting