FDA Warning Letter Slams Another Asian API Firm On Data Integrity
Data integrity warning letter to Chinese API maker reflects continuing focus of FDA enforcement efforts on the pharmaceutical industry's Asian supply chain.
You may also be interested in...
Data integrity lapses raised in FDA warning letter to California analytical testing lab shows that such issues are not confined to Asia and that FDA will, in fact, challenge US facilities to show they are managing their quality data properly.
A recent compilation of FDA warning letters shows that data integrity failings continue to plague API and finished drug manufacturing sites in Asia and Europe.
FDA import alerts hit Chinese firms and Teva; EU GMP suspensions hit Bend Research and several Indian firms.