USFDA successfully concludes inspection at Neuland Labs Bonthapally facility
Hyderabad: Neuland Laboratories Limited has announced that the United States Food and Drug Administration (US FDA) has successfully completed the inspection at the Company's Unit 1 manufacturing facility at Bonthapally, Hyderabad with no observations under Form 483.
The facility was inspected from 18th to 22nd of March 2024.
"We wish to inform you that the United States Food and Drug Administration (“US FDA”) has inspected our Unit 1 manufacturing facility at Bonthapally, Hyderabad from 18th to 22nd of March 2024. The inspection at Unit 1 by the US FDA has been successfully completed, with no observations under Form 483," the Company stated in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Read also: Neuland Labs gets USFDA EIR for Pashamylaram Manufacturing Facility
Neuland is a API manufacturing service provider, offering worldwide compliant manufacturing facilities.
The Company business is split into three core areas, Generic Drug Substances (GDS), Custom Manufacturing Solutions (CMS), Peptides.
