Centaur Pharmaceuticals, a company based in India, recently faced scrutiny from the FDA due to issues discovered during an inspection of its drug ingredients plant in Maharashtra. The FDA issued a warning letter pointing out two main concerns related to quality deficiencies and lapses in cleaning protocols for the active pharmaceutical ingredients (API) manufactured at the plant. The FDA expressed concern that these lapses could potentially lead to API contamination.
The FDA’s first observation highlighted Centaur’s failure to ensure that the API produced at the Indian facility adhered to current manufacturing standards. In response, Centaur informed the regulator that the employees involved in these situations had been either reassigned or removed from their duties.
The FDA cited three major examples of Centaur’s quality lapses. For one, the inspectors uncovered analytical worksheets, incident report forms, batch release copies and other production documents stored in laboratory drawers and cabinets with “unrestricted access and inadequate controls.” In another shortfall, the FDA said that some original manufacturing documents were “discarded and shredded without a review and a meaningful description in the logbook.”
However, the FDA is requiring Centaur to take additional action. This includes conducting a comprehensive assessment of the documentation systems used in its manufacturing and laboratory operations. Centaur must also evaluate the effectiveness of its manufacturing standards training program, particularly concerning quality control lab operations.
Regarding the second observation, the FDA noted that Centaur had not adequately cleaned its equipment and utensils to prevent contamination or material carry-over that could impact the quality of the API. As part of remediation efforts, Centaur is expected to implement appropriate improvements to its cleaning program.
While the FDA acknowledged that Centaur’s document shredding may have been a lapse in judgment rather than intentional obfuscation, similar actions by other manufacturers have also drawn regulatory attention in recent months and years.
