Now it's Sanofi-Aventis' turn in the FDA woodshed. The agency warned Sanofi about two shortfalls: Its U.S. unit failed to report adverse events on time and lacks a system to make sure it does so, FDA says, and its German unit hasn't done enough to prevent contamination of its product manufacturing.
The agency cited Sanofi about its adverse-event reporting last year, but the FDA is following up with another warning letter saying that the drugmaker's response to FDA's concerns wasn't adequate. "We remain concerned that your... adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts," FDA said (as quoted by Reuters).
FDA inspectors found the reporting problems during an inspection of Sanofi's Bridgewater, New Jersey, facility last spring. In addition to the poor adverse-event reporting, FDA said Sanofi didn't submit required updates on post-marketing studies for several drugs and on unpublished-but-complete clinical trials involving several other products.
Since then, the agency took a look at Sanofi's German unit and discovered manufacturing violations that led to microbiological contamination problems. The FDA cited a lack of proper procedures to prevent contamination and said workers weren't properly trained to prevent it, either.
A Sanofi spokesman told Reuters that the company has been working to fix the problems FDA pointed out, both in the U.S. and in Germany, and will continue working with FDA to comply with its rules.
- see the Reuters news