Manufacturing Compliance Updates In Brief From US FDA And The EU
Executive Summary
FDA issues five more drug GMP warning letters to drug manufacturers and active ingredient manufacturers at sites in India, China, and the US exhorting them to do a better job of testing ingredients and final products and to manage cross-contamination risks better. UK MHRA withdraws the GMP certificate for one Taiwanese API maker for its lack of knowledge of sterile processing. Meanwhile, FDA adds an Indian facility to its drug GMP import alert.
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Manufacturing Compliance Updates In Brief From US FDA And EU
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