OR WAIT null SECS
November 02, 2008
September 18, 2008
The US Food and Drug Administration has issued two warning letters to Ranbaxy Laboratories.
May 08, 2008
To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration's Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.
Merck and Company?s West Point, Pennsylvania facility received a Warning Letter from the US Food and Drug Administration.
February 21, 2008
The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.
January 17, 2008
Noven Pharmaceuticals received a warning letter from the US Food and Drug Administration stemming from an on-site inspection of the company?s manufacturing facility in Miami, Florida, concluded July 2007.
November 29, 2007
The US Food and Drug Administration has issued Ben Venue Laboratories a Warning Letter resulting from CGMP deviations found during an inspection of the company?s ?Propofol? injectable emulsion manufacturing facility earlier this year.
October 11, 2007
The US Food and Drug Adminstration?s Center for Biologics Evaluation and Research has issued a Warning Letter to Genzyme Corporation.
October 02, 2007
Offshore contracting is nothing new for the pharmaceutical industry. Neither is importing active ingredients, or prescription drugs, for that matter. But the authorities are having trouble keeping up with these growing international trends.
May 31, 2007
Rockville, MD (May 25)-The US Food and Drug Administration issued a Form FDA 483, Inspectional Observations, to the Liverpool, United Kingdom, facility of MedImmune, Inc., citing deviations from current good manufacturing practices.