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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
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. 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
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
Health Canada has agreed to comply with a Canadian court ruling quashing the agency’s import ban on drugs from a generics manufacturer. In a Nov. 2 statement, Health Canada retracted an update that prohibited imports from two Apotex facilities in India. Read More
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More