When FDA investigators identify potentially grave issues at a drug manufacturer’s facility, the general assumption is that the company will do its best to remedy the problem. But few things rile up the agency more than a lazy investigation—a reality Indian CMO Wintac is finding out the hard way.
The FDA blasted Wintac, the CMO arm of New Jersey-based Somerset Therapeutics, after the company performed a cursory investigation into bacterial contamination on an aseptic fill line at its Bangalore, India facility, according to a warning letter posted Tuesday.
During an inspection in November, Wintac found its operations were contaminated with ralstonia pickettii, a gram-negative bacteria. Instead of performing a wide-ranging investigation into the source of that contamination, Wintac highlighted only one possible source and ignored others, the FDA said.
FDA investigators said Wintac’s probe “lacked scientific justification” for its narrow scope—but that was only the start of its problems.
The agency said Wintac also refused to document corrective actions to prevent future contaminations after saying the identified source was only the “probable” cause of the contamination. Wintac showed similar issues with another investigation into its aseptic fill line back in July 2019, the FDA said.
The FDA cited other issues at Wintac’s plant, including inadequate smoke testing and fill-line testing that did not meet commercial specs. The agency recommended hiring a CGMP consultant to address the company’s issues.
Wintac and Somerset were the focus of a possible buyout from generics player Endo that eventually fell through back in early 2019.
In April 2018, Endo announced that it would purchase Somerset for $190 million to boost its standing in the sterile injectables manufacturing market. Endo eventually torpedoed the deal after regulatory approvals in India took longer than expected, then-CEO Paul Campanelli said at the time.
The deal would have brought Wintac’s Bangalore facility into the fold as well as eight approved drugs and a pipeline that then contained 40 products, of which more than 25 were awaiting FDA consideration.