Fierce Pharma11d
Granules slammed in FDA warning letter detailing discarded documents, intruding birds at Indian plant
Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...
FiercePharma18d
FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...
DexCom receives warning letter from FDA, sees no impact to FY25 guidance
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...