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 ...

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

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With 2024 ending, the FDA has tabulated more than 3,500 warning letters (as of mid-December) by a variety of federal offices, including the Office of Regulatory Affairs and the Center for Drug ...

The FDA’s new warning letter did not identify any new observations not already filed in the Form 483s previously issued by the company following the three inspections in June and August of 2024.

Cipla share price has risen by 10% over the past 12 months and 64% over the last three years. The company's current market ...

Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years ... compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.