India’s Zydus Lifesciences is in the FDA’s crosshairs once again, this time for a trio of unnamed violations at an injectables facility.
Following an FDA inspection that wrapped up this week, Zydus, formerly known as Cadila Healthcare, was hit with a trio of agency observations at one of its Indian manufacturing facilities. The regulator issued the write-up to Zydus’ injectables plant in Jarod, Gujarat, India, which it inspected between Feb. 24 and March 10.
In a corporate communique issued Thursday, Zydus said it was confident about “addressing and resolving the issues to the satisfaction of the USFDA,” without clarifying what those issues were.
The company didn’t immediately respond to Fierce Pharma’s request for comment on the nature of the FDA’s critiques.
“We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network,” the company continued in its filing.
The Indian-based company has had several run-ins with the FDA in recent years. Last March, Zydus’ U.S. generics unit recalled four lots of acyclovir sodium injection 50mg/mL, which is used to treat herpes and shingles, after it received “several complaints” of crystallization in vials.
At the time, Zydus said it hadn’t received any side effect reports linked to the recall, though the use of crystalized acyclovir could be fatal, the company warned. Particulate matter moving through the bloodstream can cause clots that trigger strokes or heart attacks, decrease liver or kidney function, or kill tissues or cells, Zydus said.
Meanwhile, Zydus in 2019 received 11 FDA observations at its Nesher finished dose facility in St. Louis.
Earlier that same year, Zydus revealed that a two-week FDA inspection of its Moraiya, India, formulation facility yielded 14 observations. In November, the FDA slapped Zydus’ Moraiya plant with a warning letter, which flagged “significant cross-contamination” issues.