Tag:
warning letter
Latest Headlines
Latest Headlines
Barred OTC drugmaker calls FDA oversight 'absurd'
Pax-All has suffered "hassles and inspections" that rivals in Asia haven't, the company said.
FDA cites contaminated vials, insects in APP warning letter
The FDA has posted its warning letter about APP Pharmaceuticals' New York plant, and the citations aren't pretty.
FDA scolds Merck for missing Januvia deadline
U.S. regulators have slapped Merck ( $MRK ) with a warning letter for dragging its feet in conducting a pancreatic safety study in rodents for its diabetes drug Januvia , a blockbuster product that has...
Novartis plant's quality control understaffed, inadequately trained, FDA says
Novartis ( $NVS ) temporarily pulled the curtains on its Lincoln, NE, consumer drug plant in late December. What's been going on behind those windows? Pharmalot reports that, after a recent visit, FDA
FDA slaps Sichuan on API facility shortfalls
Sichuan Pharmaceuticals is in FDA woodshed. The agency sent a warning letter to the Chinese drugmaker, scolding it for manufacturing shortfalls at a plant in Pengzhou. During a June 2010 inspection
Indian API facility slammed in FDA warning letter
The FDA has fired off a strongly worded warning letter to Yag-Mag Labs Private Limited of India, hitting the API manufacturer with an import alert. According to the FDA, the company's Hyderabad
