Sanofi-Aventis Cited for Violations

In a warning letter posted on its website in late January, the Food and Drug Administration said that , on Corporate Drive, failed to comply with certain postmarketing reporting requirements.

Because of this failure to comply, according to the letter, the FDA has concluded that Sanofi has engaged in prohibited acts that violate a regulation concerning reporting requirements.

The letter states that the failures to comply are in the areas of inadequate written procedures; failure to submit to the FDA serious and unexpected adverse drug experience reports within 15 calendar days of receipt of the information; and other violations.

According to the letter, in trying to fix the violations, Sanofi has not adequately addressed procedural deficiencies to prevent future violations of the 15-day submission, and has not provided clear instructions for investigating and following up on reports that don't contain certain minimum criteria.

In addition, the letter states that Sanofi did not fully identify all the reasons for late reporting.

The letter requires that Sanofi respond within 15 working days of receipt of the letter with specific steps taken to correct the violations.