Sanofi Lacks System To Prevent Microbial Contamination At Its German Plant, FDA Says
Executive Summary
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.
You may also be interested in...
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.
Sanofi Still Needs Fix For Adverse Event Reporting As FDA Seeks Retrospective Study, Pinches Accenture
FDA's warning letter to Sanofi-Aventis US over the firm's failure to resolve problems that have delayed adverse event reporting shows the agency is emphasizing the issue in its compliance efforts – and becoming more pointed in its requests for fixes.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.