Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...

The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and ...

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 ...

The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...

As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...

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 warned Sanofi about significant deviations from Current Good Manufacturing Practice regulations for active pharmaceutical ingredients.

Another report indicates that 79% of FDA 483 warning letters issued in 2016 cited data integrity issues2. Many quality control test procedures are still very manual and prone to human error, leading ...

But after thousands of complaints about complications, the FDA issued an open letter to veterinarians ... and pets considered in its latest warning. We also reviewed the Freedom of Information ...