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US regulator makes 2 observations at Neuland Labs facility

US regulator makes 2 observations at Neuland Labs facility

New DelhiĀ  : Drug firm Neuland LaboratoriesĀ said the US health regulator has made two observations at its manufacturing facility in Hyderabad.

“The United States Food and Drug Administration (USFDA) inspected Unit 1, manufacturing facility at Bonthapally, Hyderabad of the company from April 3-7, 2017. At the end of the inspection, there were 2 observations given under form 483,” Neuland Laboratories said in a BSE filing.

It further said, “The two observations relate to procedures followed for the annual quality standards record evaluation and cleaning and maintenance of equipment at appropriate intervals during manufacturing campaign”.

Neuland Laboratories said it has already initiated corrective and preventive actions for the observations and is confident of satisfying the FDA within the stipulated time.

Source: PTI
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