Tuesday, January 29, 2013

Inspection at Taiwan plant illustrates FDA inspections challenge Facility failed to do in-process testing or keep raw data to validate safety Read more: Inspection at Taiwan plant illustrates FDA inspections challenge - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/inspection-taiwan-plant-illustrates-fda-inspections-challenge/2013-01-29#ixzz2JObx7USd Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

With countries all over the world building up their drugmaking capabilities, the FDA is working to keep up with inspections of existing plants even as more come online. In fact, the FDA says there are now more foreign than U.S. plants that it must keep tabs on. When FDA inspectors do get in them, they often find that facilities that have been exporting products to the U.S. for years are not meeting some of the most basic manufacturing standards.
A warning letter posted today on the FDA website for a operation in Taichung City, Taiwan, illustrates the challenge. Inspectors found that the Beanne Chemical facility failed to validate its manufacturing processes; was not conducting in-process testing, only finished-product testing; and was not testing for stability that would support expiration dates.

Read more: Inspection at Taiwan plant illustrates FDA inspections challenge - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/inspection-taiwan-plant-illustrates-fda-inspections-challenge/2013-01-29#ixzz2JOc53KAG
Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

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