When FDA investigators identify problems at a drug manufacturer's facility, the general assumption is that the company will do its best to remedy them. But few things rile up the agency more than inadequate followup—a reality Indian CMO Wintac is finding out the hard way.
The FDA slapped Wintac, the CMO arm of New Jersey-based Somerset Therapeutics, with a warning letter after the company performed an insufficient investigation into bacterial contamination on a media fill line at its Bangalore, India facility.
During an inspection in November, Wintac found media fill contaminated with ralstonia pickettii, a gram-negative bacteria, according to the warning letter posted Tuesday.
Instead of performing a wide-ranging investigation into the source of that contamination, Wintac highlighted only one possible source and failed to explore others, the FDA said. Wintac's probe "lacked scientific justification" for its narrow scope, the warning letter stated.
What's more, Wintac failed to properly document its plan for corrective actions to prevent future contamination, the FDA said. The company had similar issues with another investigation into its aseptic fill line back in July 2019, the letter said.
The FDA cited other problems 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.
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