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The FDA is continuing its crackdown on Chinese drugmakers, adding three more companies this week to its import alert lists over faulty GMP practices and a refusal for inspection. Read More
Spain’s Agency of Medicines and Medical Devices has suspended the manufacturing authorization for finished processing of Madrid-based Inmunotek over GMP deficiencies. Read More
Gaping GMP holes in Swedish contract manufacturer Apotek Produktion & Laboratorier’s processes resulted in a seven-item Form 483 following an Oct. 5 to 9, 2015 inspection. Read More
The European Medicines Agency and the European Commission published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Read More
French authorities are calling for the withdrawal of Anuh Pharma’s GMP certificate after an inspection turned up 24 alleged GMP deficiencies. Read More
The FDA continues to turn up the heat on compounding pharmacies, issuing two warning letters to compounders in Kentucky and California for serious GMP deficiencies related to sterility. Read More