Laurus Labs gets 2 USFDA observations for Visakhapatnam facility
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 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 inspection was conducted from 6th February, 2023 to 10th February, 2023.
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.
