Neuland Labs gets 5 USFDA observations for Bonthapally facility

Hyderabad: City-based Neuland Labs recently said that the US health regulator has issued a total of 5 observations after inspection of its Unit 1 manufacturing facility at Bonthapally, Hyderabad.

The inspection of the unit was conducted from 17th of June to 21st of June 2019.

Also Read: US regulator makes 2 observations at Neuland Labs facility

"The inspection has been completed with five observations given under form 483. The Company has already initiated corrective and preventive actions for the observations and is confident of satisfying the FDA within the stipulated time," the company said in a BSE filing.

According to the USFDA website, Form 483 is issued to a company at the conclusion of an inspection when investigators observe any conditions that, in their judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Neuland Laboratories Limited was established in 1984 and is a publicly listed company. The company produces active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry’s chemistry needs.

Also Read: Neuland Laboratories announces successful plant inspection by USFDA, no observation