USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The United States Food and Drug Administration (USFDA) has conducted GMP inspection of the Solid Oral Formulation Facility (Plant 1) at Goa.
The inspection was conducted from 16th-20th January, 2023 and has issued Form 483 with nine observations, which will be addressed within stipulated time.
This will not have any impact on the supplies and the existing revenues from this facility and the company is committed to maintain compliances across all its facilities with cGMP quality standards at all times.
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