China-based Ningbo tripped up over raw material and finished product testing. But worse is the fact that company documentation indicated that some testing had been done when in fact it hadn't.
"This serious deviation raises concerns regarding the reliability and integrity of other data," writes FDA director Richard Friedman, in Warning Letter 320-11-010. He dismisses the company's commitment to improve its quality control unit--made in response to the Form 483 inspection report that followed the FDA visit--as inadequate to determine "the extent and impact of the problem."
The warning letter, to Chairman Grant Wu, cites three GMP violations found during the late October 2010 inspection of the plant in Ningbo: Failure of the QC unit to ensure that raw materials have been tested; failure to ensure that purchased APIs are in compliance and meet specifications; and failure to conduct an identity test of each batch of incoming material.