Neuland Labs gets 5 observations from USFDA for Unit 1 of Bonthapally plant

Drug firm Neuland Laboratories Friday said it has received five observations from the US health regulator after inspection of Unit 1 of its facility at Bonthapally in Telangana. The United States Food and Drug Administration (USFDA) inspected our Unit 1 manufacturing facility at Bonthapally from June 17 to 21, 2019 Neuland Laboratories said in a filing to BSE.

"The inspection has been completed with five observations given under form 483," it added. The company has already initiated corrective and preventive actions for the observations and is confident of satisfying the FDA within the stipulated time, Neuland Laboratories said.

"This is a regular surveillance audit by USFDA, and no data integrity issues were observed during the inspection," it added. The company, however, did not disclose the nature of the observations made by the US regulator.

Shares of Neuland Laboratories Friday ended at Rs 521.25 per scrip on the BSE, down 3.09 per cent from its previous close.