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 letters, dated Dec. 19 ... This latest claim, separate and distinct from the contractual violation charges that SCO filed against IBM last March, maintains that the use of the ABIs by ...

Viatris took measures to correct the misstep, including implementing a data integrity remediation plan and firing certain staffers responsible for the violation, according to the warning letter ...

Integra said the warning letter states that premarket approval applications for Class III devices to which the quality system regulations violations are reasonably related will not be approved ...