FDA Issues Warning Letter To India’s Zydus Over Recent Results

Zydus Lifesciences is currently facing heightened oversight from the FDA, which has issued a warning letter to the company's production plant in Jarod. This comes after Zydus received two Form 483 citations within a single month earlier this year, due to inspections at different manufacturing locations in India. The FDA's criticisms included concerns about untrained staff handling sample collections and inadequate assessments of drug batches.

In a financial filing dated August 30, Zydus revealed that its injectables facility in Jarod, near Vadodara, received a warning letter following an inspection conducted from April 15 to 23. Zydus said, “The company will take all necessary steps to work with U.S. FDA towards earliest remediation of the above facility.”

Zydus noted in its response that although the latest FDA warning did not identify any data integrity concerns, it did not specify any particular violations. While the warning will not affect the current supply from the facility, it does impose restrictions on new product launches—an important factor for the company's expansion in the U.S. market.

In early May, a Zydus facility in Gujarat, India, received a Form 483 following an inspection in April, which revealed ten manufacturing procedural issues. Among the findings, the FDA noted that drug lots produced with equipment potentially exposed to cross-contamination were released to the U.S. without proper investigation. Earlier, in March, another Zydus site in Matoda, India, also received a Form 483. This inspection uncovered four concerns, including inadequate cleaning and maintenance of equipment.