The USFDA concluded an inspection at Zydus Lifesciences’ Unit-2 manufacturing plant in Ankleshwar, Gujarat, from January 19th to 23rd, 2026. The inspection resulted in 3 observations. The company stated that no observations related to data integrity were noted. Zydus will work with the USFDA to address these observations.
Inspection Overview
An inspection by the United States Food and Drug Administration (USFDA) at Zydus Lifesciences’ Unit-2 manufacturing plant in Ankleshwar, Gujarat, has been successfully completed. The inspection took place between January 19th and 23rd, 2026.
Key Findings
At the conclusion of the inspection, the USFDA issued a total of 3 observations to the company. Importantly, it was noted that there were no observations related to data integrity. This is a positive outcome for Zydus, indicating a strong adherence to data management protocols.
Company Response
Zydus Lifesciences has committed to working closely with the USFDA to address the observations promptly. The company’s proactive approach aims to ensure continued compliance and maintain the high standards of its manufacturing operations. Zydus expects to resolve these matters expeditiously and does not anticipate any significant disruption to its production schedule.
Source: BSE
