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The FDA is continuing its nationwide effort to single out compounding facilities that don’t conform to GMP regulations, and it blasted pharmacies in Pennsylvania, Massachusetts and Texas with Form 483s for inadequate sterilization practices. Read More
A House committee is asking for a review of the FDA’s progress in ensuring the security of foreign facilities’ supply chains and toughening the agency’s approach to inspections at those facilities. Read More
The FDA said Wednesday that its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More
The FDA is asking India-based Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP violations. Read More
During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which they uncovered 27 critical findings, 169 major and 155 minor findings, according to a report. Read More
A House of Representatives committee is asking for a review of the FDA’s progress in ensuring the security of foreign facilities’ supply chains and toughening the agency’s approach to inspections at those facilities. Read More
A December FDA warning letter to China’s Zhejiang Hisun Pharmaceutical released Tuesday outlines the company’s “systemic data manipulation” and cGMP deficiencies uncovered during a March 2015 inspection. Read More