Last Updated on October 17, 2024 by The Health Master
Drug firm Lupin on Sunday said it has received a warning letter from the US health regulator for its Somerset facility in the US.
The United States Food and Drug Administration (USFDA) had inspected the company’s Somerset, New Jersey, facility from September 10, 2020, to November 5, 2020, Lupin said in a regulatory filing.
“The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility,” it added.
Lupin is committed to addressing the concerns raised by the USFDA and will work with the FDA and the New Jersey district to resolve these issues at the earliest, the filing said.
“We uphold quality and compliance issues with utmost importance and are committed to be compliant with ‘good manufacturing practice’ standards across all our facilities,” it added.
When USFDA finds that a manufacturer has significantly violated USFDA regulations, it notifies the manufacturer. This notification is often in the form of a warning letter.
Earlier, in November 2020, Lupin in a regulatory filing had said that the USFDA had issued 13 observations after the inspection of its subsidiary’s Somerset facility.
The company had said that it was confident of addressing these observations and would work closely with the agency to address their concerns. The facility contributes less than 5 per cent of the company’s global revenues, Lupin had said.
Application Forms: Drugs, Cosmetics and Medical Devices
Schedules – Drugs and Cosmetics Act 1940 and Rules 1945
CSIR gets DCGI nod for Clinical trials of Colchicine to treat…
GST rates for C-19 medicine and goods: 44th GST Council Meeting
Covaxin: Bharat Biotech to release 3rd phase efficacy data soon
Supreme Court refuses to waive off final exams of PG courses
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
