Zydus Oncology Site Inspection: USFDA Closes with Observations

Zydus Lifesciences Ltd announced the closure of a USFDA follow-up inspection at its oncology injectable site near Matoda, Ahmedabad. The inspection, held from June 9-18, 2025, resulted in two observations unrelated to data integrity. Zydus plans to address these issues swiftly in coordination with the USFDA.

Zydus Lifesciences Ltd announced on Wednesday the closure of a follow-up inspection by the US Food and Drug Administration (USFDA) at its oncology injectable facility near Matoda, Ahmedabad. The inspection concluded with two observations.

The USFDA's assessment took place from June 9 to June 18, 2025, at the company's facility situated in SEZ 1, as per a regulatory filing by Zydus Lifesciences. Importantly, none of the observations pertained to data integrity.

Zydus Lifesciences emphasized its commitment to addressing the observations promptly and working in close collaboration with the USFDA to ensure compliance.

(With inputs from agencies.)