Laurus Labs gets USFDA EIR for Visakhapatnam facility
Hyderabad: Laurus Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for the formulations manufacturing facility Unit–2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
The USFDA had conducted the inspection from 6th February, 2023 to 10th February, 2023 and issued Form 483 with two observations for the said facility.
Read also: Laurus Labs gets 2 USFDA observations for Visakhapatnam facility
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.
"Further to our intimation dated February 10, 2023, on the Inspection conducted by the United States Food & Drug Administration (USFDA) at our formulations manufacturing facility Unit–2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh from 6th February, 2023 to 10th February, 2023, we wish to inform you that the Company has received the Establishment Inspection Report (EIR) from USFDA." the Company stated in a BSE filing.
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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.
