Time Waits for No Lab, Ranbaxy Learns
This article was originally published in The Gold Sheet
Time waits for no lab learn Ranbaxy and new owner Daiichi Sankyo as stock sinks after FDA sanctions firm for holding stability testing samples in refrigerators until its overworked lab could get around to testing them. Lab was backdating same-day testing of 30-, 60- and 90-day samples, FDA said as it slapped Ranbaxy with application integrity letter.
You may also be interested in...
Cadila (now Zydus), Wuxi, Accu-Biochem, Agropharma, Dr Retter stung by US FDA inspections that focused on failings in a range of core quality areas.
COMPETES Act also includes enhanced penalties for drug makers who falsify or destroy records, power for the FDA to recall harmful drugs, funding for drug manufacturing technology and additional supply chain flexibility efforts.
A decade ago, Dinesh Thakur was able to perceive data integrity issues at Ranbaxy because of his unique position in the company. Today, he’s working to help pharmaceutical companies monitor their global manufacturing networks to detect such issues wherever they might occur.