13 FDA observations on Dr Reddy’s plant send shares to 3 year low
Indian pharmaceutical firm Dr Reddy’s has seen its shares drop on the Bombay Stock Exchange to their lowest point in 31 months after the FDA issued 13 observations against its oncology formulation facility in Duvvada, Visakhapatnam.
The company stated: “The audit of company’s formulation manufacturing facility at Duwada, Visakhapatnam, by the US FDA, has been completed on March 8, 2017. The company have been issued a Form 483 with 13 observations, which the company is addressing.”
This latest inspection came after the FDA originally examined the facility in November 2015; after being presented with observations for correction including unsatisfactory quality control procedures and contamination issues, Dr Reddy’s claimed to have taken remedial action and sought a reinspection, expecting to pass cleanly.
Instead, while the observations have not been specified, the company was hit by a wave of new issues with the facility, which produces hormonal and cytotoxic injectables.
The Duvvada facility is not the only one of Dr Reddy’s facilities to be targeted by the FDA; the company has also been issued unsatisfactory observations for its Srikakulam and Miryalaguda plants in 2015, again regarding quality control issues.
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