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US FDA hands Neuland Laboratories Form 483 after plant inspection

By Gareth MacDonald+

10-Apr-2017
Last updated on 19-Apr-2017 at 16:58 GMT2017-04-19T16:58:24Z

iStock/Bet_Noire
iStock/Bet_Noire

The US FDA has found fault at Neuland Laboratories Limited manufacturing facility in Bonthapally, India.

The US Food and Drug Administration (FDA) issued Neuland with a Form 483 detailing two observations after a five day inspection of the site near Hyderabad on April 7.

The observations related to “procedures followed for the annual quality standards record evaluation” and “cleaning and maintenance of equipment at appropriate intervals during manufacturing campaign” according to a Neuland Bombay Stock Exchange (BSE) filing .

The firm said it “has already initiated corrective and preventive actions for the observations and is confident of satisfying the FDA within the stipulated time.”

The facility – known as Unit-1 - is situated at Bonthapally Village in Medak District. It houses seven active pharmaceutical ingredient (API) production lines and quality assurance & quality control (QA&QC) and Regulatory Affairs (RA) units.

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