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Two lawmakers are mulling contempt proceedings against outgoing Valeant CEO J. Michael Pearson after he failed to provide a deposition on Friday as part of an investigation into drug pricing. Read More
British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP certificate. Read More
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization. Read More
The fragmented nature of the modern manufacturing sector necessitates focusing less on technology and more on integration, according to an industry expert. Read More
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after apparently finding numerous GMP deficiencies. Read More
Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Read More
Cynthia Schnedar, director of CDER’s Office of Compliance, stepped down from her role on March 18 to take an unspecified private sector job, according to an email from CDER Director Janet Woodcock. Tom Cosgrove, who until recently served as director of the OC’s Office of Manufacturing Quality, assumed her position on April 4. Read More