Indian drugmaker Aurobindo’s Eugia manufacturing arm suffered another blow from the FDA after the U.S. regulatory agency issued a warning letter in the wake of previous inspections.
Eugia’s terminally sterilized product line at its Unit III plant on the edge of Hyderabad, India, was issued the warning letter after being hit with an official action indicated (OAI) notice in May, Aurobindo said in an Aug. 16 filing.
An OAI designation “indicates that an establishment failed to meet either regulatory or administrative requirements and may pose a hazard to public health,” according to an FDA document. The designation, as is the case with Unit III, can result in further regulatory actions or approval delays.
“Subsequent to OAI, the unit has received a Warning Letter,” the company said in its filing. “There is no impact on the existing supplies to the U.S. markets.”
The news saw Aurobindo’s shares drop as much as 6.39% in intraday trading Friday.
The facility had only recently restarted production, which had been temporarily halted to address certain FDA observations that followed an inspection that wrapped up in early February.
Eugia has had a rocky journey with the FDA since late 2023. The Aurobindo subsidiary has tallied four Form 483s at various facilities throughout India since the start of the year. In December 2023, the FDA issued a citation for a plant in New Jersey that Aurobindo has since agreed to sell.