FDA hits Zydus with trio of observations

March 11, 2022

Indian-based pharma company Zydus Lifesciences just got hit with a triple whammy by the U.S. FDA.

According to a letter shared by the company, the FDA issued Zydus (formerly Cadila Healthcare) three observations following a facility inspection. The injectables facility, which the agency inspected from February 24 to March 10, is in Jarod, Gujarat in western India.  

No explanation has been offered as to the seriousness of the observations that were issued and FDA inspection reports haven’t made the issues observed public yet.  

“We are confident of addressing and resolving the issues to the satisfaction of U.S. FDA,” said Zydus. The company added that they will work to continue meeting FDA manufacturing standards.

But this isn’t the first time the Indian drug company has been in hot water with the FDA.

In March 2021, the company voluntarily recalled four lots of Acyclovir Sodium Injection, a medicine used to treat herpes and shingles. Zydus sent out the recall after receiving reports of crystallization inside the drug’s glass vials. Crystals in the drug's liquid could cause blood clots resulting in stroke, heart attack, or liver and kidney damage, though the company had not received any reports of adverse events at the time of the product recall.

Zydus also received warning letters from the agency in 2019 and 2015 over quality control problems at factories in India.