FDA 483 - LNK International, Inc. - March 07, 2017

LNK International, Inc. in Hauppauge, NY, a pharmaceutical drug manufacturer, was cited with two observations during an FDA inspection. The first observation noted a failure to prevent contamination due to uncovered empty bottles on a liquid packaging line. The second observation detailed significant issues with electronic recordkeeping, including a failure to maintain backup files and inadequate controls over computer systems and data accuracy.