FDA compliance vet heads to India-based Lupin after long public career
In a rare move, a long-time veteran of the FDA’s pharma quality and compliance team is moving over to an India-based generic drugmaker with a history of noncompliance.
Diana Amador-Toro, who spent almost four decades with FDA including stints as a program director for the office of pharmaceutical quality operations, was hired in April by Indian generic drug manufacturer Lupin as the company’s senior vice president of global compliance, where she will be handling the company’s compliance function including training, internal audits and investigations.
According to her LinkedIn, Amador-Toro has amassed well over 36 years of FDA field experience in investigations and compliance activities, contributing to ICH and FDA guidance documents as well as having conducted GMP and pharmaceutical quality training in Europe and South America. Before serving as a program director, she was responsible for over hundreds of field employees in seven districts and three laboratories including the ORA’s forensic chemistry center.
While a few former FDA employees have gone on to work for manufacturers in the past, as India’s CNBC affiliate highlighted, the fact that Lupin was able to net a compliance officer is as major catch for the manufacturer. However, Amador-Tor is joining a company that has run afoul with US regulators and has been cited multiple times.
#Lupin hired an ex-US #FDA officer to head their compliance operations. However, this is not the first time a former #US FDA officer has joined the Indian #pharma sector. @ekta_batra explains the trend#clutterbreaker pic.twitter.com/IpGgBJQvHT
— CNBC-TV18 (@CNBCTV18News) June 2, 2022
In 2021, Lupin subsidiary Novel Laboratory’s facility in Somerset, New Jersey had GMP violations such as an inadequate cleaning procedure and quality control procedures. Drug residue on tablet presses and a failure to validate the manufacturing process after equipment changes were just some of the issues raised by an inspection.
And in April, Lupin was slapped with a Form 483 following an inspection carried out at their manufacturing facility in Tarapur, India.
Amador-Toro did not immediately respond to a request to comment on her new role.