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Aventis Pasteur draws warning letter

Executive Summary

FDA cites capping defects in lots of Genzyme's Thymoglobulin in warning letter to Aventis Pasteur regarding manufacturing facility in Lyon, France. In addition to other quality control failures, "numerous lots of Thymoglobulin did not meet specifications for capping defects during filling and capping operations for which you are the contract manufacturer. Nevertheless, the quality control unit did not thoroughly investigate these defects," an Aug. 16 FDA 1warning letter states. Letter follows inspection that took place in mid-March and late April 2004. Aventis Pasteur says it has responded to letter, and all issues cited are either resolved or in the process of being resolved...

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