Wintac, a contract manufacturer of sterile drugs in India, has been hit with an FDA warning letter.
Posted this week, the warning letter is based on an investigation the agency conducted at Wintac’s facility in Bangalore that resulted in a Form 483. After that investigation, the FDA said that Wintac failed to get its act together and adequately address the agency’s concerns about Ralstonia pickettii contamination on its media fill line.
“You considered a limited portion of the processing train to be a potential source of the Ralstonia pickettii contamination,” the agency said. “However, your investigation lacked scientific justification for its narrow focus and for ruling out other meaningful failure modes. Your investigation did not identify any CAPA to resolve the potential root causes, and you closed the investigation without sufficiently assessing how other batches manufactured on the line may have been or will be compromised.”
In response to the warning letter, the FDA said that Wintac will need to provide a comprehensive third-party assessment of its media fill failures.
The FDA also blasted Wintac for inadequate smoke studies for its aseptic processing operations.
FDA warning letters in pharma have been few and far between this year as the agency has halted foreign and domestic inspections. But earlier this summer, the agency announced that it will once again resume limited “mission critical” inspections of domestic facilities when it is safe to do so.
