# FDA WARNING_LETTER - Sanofi-Aventis U.S. LLC - May 13, 2010

Source: https://www.globalkeysolutions.net/records/warning_letter/sanofi-aventis-us-llc/3f884094-3cf6-4ec2-bcb3-0fc62df41410

> FDA WARNING_LETTER for Sanofi-Aventis U.S. LLC on May 13, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sanofi-Aventis U.S. LLC
- Inspection Date: 2010-05-13
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: 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

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- [District Director](https://www.globalkeysolutions.net/people/diana-amador-toro/66f3f6c5-4cfe-4f40-b4d4-d24ed4618e64)

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