As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Food and Drug Administration (FDA) warnings could result in civil monetary and other penalties to investigators who fail to report results on ClinicalTrials.gov. On August 31, the FDA distributed its ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...

The FDA earlier this month issued separate warning letters to drug ingredient firms Nuowei Chemistry and Innovation Pharmaceutical. Given the scope of the production infractions, both companies ...

FDA Warning Letter expands scope of FDA Form 483 The ... such records and reports relating to the conduct of a clinical investigation. 11 Companies should conduct mock inspections to prepare ...

The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...

Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...

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 U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.

French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following ... personnel attrition of trained investigators, process knowledge gaps ...

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even though the company recalled the devices last year. Hologic Inc.