The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and inadequate quality controls. The agency demands a comprehensive review, ...
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its ...
FDA Warning Letter expands scope of FDA Form 483 The Warning Letter to Applied Therapeutics identified critical issues, specifically regarding dosing error, data integrity and protocol adherence ...
The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...
The FDA has slapped a warning letter on Sanofi’s Genzyme facility ... and yielded a Form 483, which the FDA says Sanofi responded to by late July. The letter itself, which marks an escalation ...
The warning letter did not identify any new observations that had not already been provided in the Form 483s previously issued to the company by the FDA at the conclusion of its three inspections ...
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