USFDA issues Form 483 with 2 observations to Laurus Labs for Visakhapatnam facility

"The observations are procedural in nature. "The company will address the observations within stipulated timelines," Laurus stated.

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USFDA Inspection audit Form 483
USFDA Form 483

Last Updated on December 31, 2023 by The Health Master

Telangana: Laurus Labs has announced that the company has received Form 483 with two observations from the US Food and Drug Administration (USFDA) after an inspection at the company’s formulations manufacturing facility at Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.

An USFDA 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 inspection was conducted from 6th February, 2023 to 10th February, 2023.

“This is to inform you that the USFDA today completed inspection of our formulations manufacturing facility Unit–2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh,” the company stated in a BSE filing.

“The observations are procedural in nature. “The company will address the observations within stipulated timelines,” Laurus stated.

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.

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