Cadila Healthcare gets 11 USFDA observations for St Louis facilities

The United States Food and Drug Administration (USFDA) inspected the manufacturing facilities of Nesher Pharmaceuticals (USA) LLC located at St Louis, Missouri, the USA from May 13 to May 31, 2019, Cadila Healthcare said in a filing to BSE.

New Delhi: Drug firm Cadila Healthcare Monday said the US health regulator has issued a total of 11 observations after inspection of its manufacturing facilities at St Louis in the US.

The United States Food and Drug Administration (USFDA) inspected the manufacturing facilities of Nesher Pharmaceuticals (USA) LLC located at St Louis, Missouri, the USA from May 13 to May 31, 2019, the company said in a filing to BSE.

Nesher Pharmaceuticals LLC is a 100 per cent subsidiary of Zydus Pharmaceuticals USA, it added.

"The inspection concluded with 3 observations at one facility and 8 observations at the other facility of Nesher Pharmaceuticals with a recommendation for Voluntary Action Indicated (VAI)," Cadila Healthcare said.

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This was a product-specific pre-approval inspection with general current good manufacturing practice (cGMP) and there were no data integrity related observations, it added.

"The company is confident of addressing these observations and responding to the USFDA at the earliest," Cadila Healthcare said.

As per the USFDA, VAI means that "objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action".

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