Last Updated on December 31, 2023 by The Health Master
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 October 24th, 2022 to October 28th, 2022.
“We have been issued a Form 483 with one observation.” “The observation is procedural in nature,” the company stated in a BSE filing.
At the conclusion of an inspection, a USFDA Form 483 is issued to firm management if an investigator(s) observes any conditions that, in their opinion, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts.
“The company will address the observation within the stipulated timelines,” Laurus Labs said.
Laurus Labs is an Indian pharmaceutical company headquartered in Hyderabad. Anti-retroviral, Hepatitis C, and oncology medications are among the company’s primary focus areas.
Most of the Laurus Labs manufacturing facilities are approved by major regulatory authorities USFDA, WHO-Geneva, UK-MHRA, etc.
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