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Latest Headlines

CSL nets closeout letter after FDA violations

After more than two years of manufacturing problems, CSL Biotherapies cleaned up its act, receiving a closeout letter from the FDA.

FDA wags finger at Sanofi for no-nos at vaccine plants

The FDA admonished Sanofi Pasteur on more than two dozen counts for "objectionable" conditions in two plants in Canada and France, according to a warning letter dated July 12 and made public July 24.

FDA to Congress: Agency not the cause of drug shortages

When it comes to drug shortages, the FDA says it is not the problem. It is part of the solution.

FDA cites Siemens again for diagnostics quality manufacturing violations

The FDA smacked Siemens Healthcare with the second warning letter in a month concerning quality and manufacturing issues with some of its diagnostics products.

FDA targets Covidien over stapling device safety issues

The FDA is citing Covidien for not taking prompt steps to correct potential problems with a tissue stapling system, three years after receiving initial complaints that the product caused deaths and serious injuries.

FDA cites J&J's McNeil-PPC unit for flawed lubricants

A unit of Johnson & Johnson is facing some tough FDA scrutiny over how it manufactures device products ranging from sexual lubricants to tampons, feminine napkins and dental floss.

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
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