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US FDA reports violations at Strides Shasun facility

Strides Shasun Ltd. said the U.S. Food and Drug Administration issued a Form 483 recording three violations at its Bangalore facility in Karnataka, India.

The company said none of the observations were related to data integrity or quality control and it will address them comprehensively.

Strides' flagship Bangalore plant, which underwent the inspection in May, has a host of key products pending approval with the regulator.