US FDA hands Neuland Laboratories Form 483 after plant inspection

By Gareth Macdonald contact

- Last updated on GMT

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.

Related topics: Regulatory & Safety, Regulations, QA/QC

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