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The FDA issued Kath Khemicals a Form 483 after an inspection of its Sterling Heights, Michigan facility revealed problems with batch reviews, product testing and cleaning, among other deficiencies. Read More
Health Canada issued an updated risk classification guide to ensure consistent decisions by agency inspectors when classifying GMP observations by risk and assigning overall compliance ratings to an inspection. Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More
Oregon’s Senate advanced legislation that would introduce a drug cost and price transparency program, sending it to Gov. Kate Brown (D) for signature. Read More
The 1st Circuit Court of Appeals in Boston declined to take up Medicis’ appeal last month before March 12, when the case was scheduled to go to trial. Read More
The firm’s stability studies did not sufficiently ensure that its OTC drug products remained within specifications through their labelled expiry period. Read More
The FDA slapped TrueCare Biomedix with a Form 483 for numerous procedural issues and violations observed during a November inspection of its facility in Gujarat, India. Read More
The FDA issued A&Z Pharmaceutical a Form 483 for deficiencies at its Hauppauge, New York facility that included improper storage conditions, poor calibration practices and failure to review batch failures. Read More
The FDA served Korean drug manufacturer Nowcos a warning letter after an inspection revealed multiple validation deficiencies and inadequate stability studies. Read More