Aurobindo subsidiary Eugia is back in hot water with the FDA after a recent plant inspection yielded yet another Form 483—this time in India.
Following an inspection of an Eugia injectables facility in Telangana, India, the FDA issued a formal rebuke laying out seven manufacturing observations, parent company Aurobindo said in a recent filing.
The observations, at a Eugia unit called "Eugia SEZ," are “procedural in nature," Aurobindo said. The company plans to respond to the FDA "within the stipulated time frame."
The FDA carried out its inspection from Feb. 19 to Feb. 29, according to the company's filing.
Meanwhile, another Eugia unit, dubbed Eugia Pharma Specialties, has restarted production on its terminally sterilized product line at its Unit III plant on the edge of Hyderabad, India, Aurobindo noted in a separate filing. Production had temporarily stopped at the plant to address certain FDA observations following another recent inspection that wrapped up on Feb. 2.
Eugia’s troubles in India come about a month after the U.S. FDA posted a Form 483 write-up detailing production faults at the subsidiary’s facility in New Jersey, where the agency carried out an inspection between Dec. 11 and Dec. 22, 2023.
During the New Jersey site visit, FDA officials made note of “construction activities” in a warehouse near the firm’s microbiology lab, which could have posed a contamination risk.
FDA inspectors also flagged damage to an HVAC system located near an aseptic processing line, plus what “appeared to be damage caused by ceiling leaks” near the company’s aseptic processing area.
Curiously, that Eugia site in New Jersey was recently snapped up by Empower Pharmacy, a maker of compounded drugs. Empower will assume ownership of the 17,000-square-foot plant and will take over its workforce, too.
Eugia and Empower are also expected to form a “contract manufacturing relationship,” Empower said at the time.
Aside from Eugia’s manufacturing shortfalls, its parent company, Aurobindo, received its own Form 483 wrist-slap in late December. Ultimately, the FDA classified the Aurobindo facility, located in the Indian state of Andhra Pradesh, with a “voluntary” action tag, meaning the agency didn't require the company to make any changes.