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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
Three stem cell treatment centers owned by the same physician have been hit with an FDA warning letter critical of their recordkeeping and lack of required licenses for their clinical procedures. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which they found 27 critical findings, 169 major and 155 minor findings. Read More
The FDA is asking 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
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
Since January 2015, the FDA has issued 16 drug GMP warning letters covering 19 facilities, and more than three-fourths of those letters cited data integrity issues. Read More
The FDA has hit three more compounders — two in California and one in North Carolina — with warning letters, bringing to 25 the number of warnings issued to this industry last year. Read More