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.

579
USFDA Form 483
USFDA Form 483

Last Updated on October 9, 2024 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.

USFDA issues 2 observations to Natco Pharma for Vizag facility

USFDA issues Form 483 with zero observation to Solara Active Pharma Sciences Vizag Facility

USFDA issues Form 483 with 9 observations to Indoco Remedies, Goa

USFDA issues Form 483 with 8 observations to Jubilant

USFDA issues Form 483 with 8 observations to Lupin

USFDA issues Form 483 with 10 observations to Aurobindo Pharma

Drug recall: Over 34,000 bottles of Diltiazem HCL capsules recalled due to this reason

Dissolution test: Importance in Pharma Industry

Cosmetics: Chemicals in Nail Polish, Shampoo may raise Type 2 Diabetes risk

USFDA gives nod for generic Lenalidomide capsules

PCI issues notification on Exit Examination for D.Pharm course

Updated list of Medical Device Testing Laboratories (MDTLs)

Lux level in Industry (Pharma, Cosmetics, Homeopathy & Medical Devices)

Aerosols in Cosmetics

Latest IPC Alert – Indian Pharmacopoeia Commission

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news