India’s Zydus Hit With FDA Warning Letter
September 6th, 2024 // 8:49 am @ jmpickett
Zydus Lifesciences has been under intense FDA scrutiny in recent months, and received a warning letter for the Indian drugmaker’s production plant in Jarod in July 2024. Earlier in 2024, Zydus received two FDA 483s in a month after FDA inspections of two manufacturing sites in India.
At that time, FDA stated the plants had issues that included unqualified employees doing sample collections, as well as inadequate evaluations of drug batches. This time, the Zydus injectables facility in Jarod in the area of Vadodara received a warning letter after an April 15 inspection, according to a Zydus financial document released on August 30, 2024.
The financial statement said that Zydus would do everything it could to work with the FDA to remedy cGMP issues at the named Zydus plants. No specific FDA criticisms were noted in the firm’s response, but Zydus stated that the FDA warning letter didn’t mention any data integrity problems. The company also said the warning won’t affect existing drug supplies from the plant. But it will restrict new product launches for now.
In May 2024, the Zydus site in Gujarat, India, received an FDA 483 related to an April audit. During the inspection, FDA auditors listed 10 observations of various manufacturing issues. For instance, FDA found that drug lots made on equipment that were exposed to cross-contamination were put on the US market without a complete investigation.
Three weeks before the FDA gave the company that 483, the firm’s facility in Matoda, India, also got a 483 after a March audit. That FDA inspection led to four observations, such as the company’s failure to properly clean and update equipment.
