Manufacturing Compliance Updates In Brief From US FDA And The EU

 
• By Joanne S. Eglovitch
  
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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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Firms should be doing a better job of testing ingredients and final products and they should be managing cross-contamination risks better, FDA said in several recent warning letters, including one to a US firm that was manufacturing topical drugs and pesticides on the same line. Meanwhile, an active pharmaceutical ingredient maker in Taiwan lost its EU GMP certificate over an apparent lack of knowledge about sterile processing, and FDA placed a firm in India on its drug GMP import alert.

FDA on April 16 issued a warning letter to contract manufacturer Ei LLC in Kannapolis, North Carolina, for failing...

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