The Company has taken multiple steps after the inspection to address the observations received from US FDA during the inspection. The Company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facility.
This warning letter does not affect the existing business of the company in the US and the existing product supplies from the Moraiya facility will continue.
Zydus remains committed to patient safety and meeting the expectations of regulatory compliances. After the inspection of Mbraiya facility, Zydus Cadila has successfully completed USFDA audits of formulations manufacturing facility at Baddi, and API manufacturing facilities at Ankleshwar and Dabhasa during the year.
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