Laurus Labs gets 1 USFDA observation for Visakhapatnam facility
Hyderabad: Laurus Labs today announced that the US Food and Drug Administration (USFDA) has concluded a PreApproval Inspection (PAI) with one observation at its manufacturing facility at Unit-5, Parawada, Visakhapatnam, Andhra Pradesh.
The inspection was conducted from 24th October 2022 to 28th October 2022.
"We have been issued a Form 483 with one observation. The observation is procedural in nature," 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.
"The Company will address the observation within stipulated timelines," Laurus Labs said.
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Laurus Labs is an Indian pharmaceutical company headquartered in Hyderabad. The Company's major focus areas include anti-retroviral, Hepatitis C, and Oncology drugs.
Most of the Laurus Labs manufacturing facilities are approved by major regulatory authorities USFDA, WHO-Geneva, UK-MHRA, etc.
