Home health remedies FDA puts India’s Wintac on blast for lackadaisical probe into bacterial contamination

FDA puts India’s Wintac on blast for lackadaisical probe into bacterial contamination

5
0
SHARE

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. 

Fierce Webinar

Leveraging Innovative Technologies, Best Practices and Strategies to Accelerate Biologics Development and Commercialization

Learn practical implementation of innovative technologies and solutions such as multi-attribute method, modernized cell line development workflow using high-yield cell lines and automated systems, next generation purification resins. The webinar will also showcase best practices and strategies such as phase appropriate quality systems, and integrated drug substance – drug product solutions that leverage standardized technology platforms.

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. 

RELATED: Endo terminates $190M deal for sterile injectable player

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here

18 − 1 =