Sanofi GMP Problems Require Top-level Sit-down With FDA, But Product Impact Limited So Far
Agency’s warning letter also includes an uncommon request for a “global assessment” of operations. FDA says sterility of TheraCys lots manufactured since 2000 cannot be assured; company has halted manufacture of the bladder cancer drug and set limits on orders of its Pentacel vaccine.
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Upper management at Novartis and Sandoz are responsible for repeated cGMP violations at three Sandoz plants, FDA suggests. The agency’s warning letter, aimed at three sites in North Amercia, includes what may become new biolerplate instructions on drug shortages.
Sanofi-Aventis has not established or followed appropriate written procedures to prevent microbiological contamination of drug products at its manufacturing facility in Frankfurt, FDA told the company.