While the famous half-horse, half-man of classical lore is often the one shooting the arrows, it's Centaur Pharmaceuticals that recently found itself in the FDA's crosshairs.
In a warning letter published last week, the FDA chided Centaur for production shortfalls found during an inspection of the company’s Maharashtra, India, drug ingredients plant. Centaur’s active pharmaceutical ingredients (API) rebuke centered on just two observations about quality deficiencies and lapses in cleaning protocols. The latter problem carried the risk of API contamination, the FDA said.
On the whole, Centaur’s quality unit failed to make sure API manufactured at the Indian drug ingredients plant complied with current manufacturing standards, the agency said in its first observation.
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.”
Centaur told the regulator that employees involved in those situations had either been reassigned or removed from their duties, according to the warning letter.
Still, the FDA is demanding Centaur take further action, including a complete assessment of documentation systems used throughout its manufacturing and laboratory operations. Centaur is also on the hook to weigh its manufacturing standards training program effectiveness as it pertains to quality control lab operations, the FDA said.
As for Centaur’s second observation, the FDA said the company failed to clean equipment and utensils to prevent contamination or carry-over of material that could alter the quality of the company’s API.
Among other remediation efforts, Centaur is expected to chart appropriate improvements to its cleaning program.
While Centaur’s document shredding maneuvers seem more like a lapse in judgment rather than intentional obfuscation, similar behaviors have landed other manufacturers in hot water in recent months and years.
Look no further than India’s Intas, which the FDA blasted for a “cascade of failure” after it found employees destroying documents related to medicines sold in the United States.
Despite last week’s wrist-slap, Centaur has largely avoided FDA scrutiny in recent years. Back in 2019, for instance, Centaur got the regulator’s OK at its Pune finished dosage facility to expand in the U.S. market after successfully completing an FDA audit with a “No Action Indicated” tag.
Founded in 1978, Centaur says it offers a mix of capabilities across the pharma value chain, including producing APIs, formulation, contract research and manufacturing. As of 2019, the company billed itself as a $100 million Indian drugmaker with exports to 110 countries.