FDA to Taiwan’s Beanne Chemical: Conduct Comprehensive GMP Assessment

The FDA is recommending Tawian’s Beanne Chemical perform a comprehensive good manufacturing practice (GMP) assessment after finding it did not validate any manufacturing steps to produce finished product for the U.S. market. The company had said during a May 2 to 4 inspection it had not conducted process validation, cleaning validation or equipment qualification, according to a Dec. 19 warning letter posted recently online.
Drug Industry Daily