USFDA issues Form 483 with 6 observations to Cipla

The company said the Goa plant recently underwent a United States Food and Drug Administration (USFDA) inspection from August 16 to 26, 2022.

3804
USFDA Inspection audit Form 483
USFDA Form 483

Last Updated on December 31, 2023 by The Health Master

The pharma major, Cipla, has announced that the company has received six observations from the US Food and Drug Administration (USFDA) following the inspection conducted in August 2022 at its Goa plant.

The company said the Goa plant recently underwent a United States Food and Drug Administration (USFDA) inspection from August 16 to 26, 2022.

Earlier, the USFDA inspected the company’s Goa manufacturing facility in September 2019. A warning letter for the same was received by the company in February 2020.

The company further informed that on the conclusion of the inspection, the company has now received 6 observations, with some referencing to the observations made during the September 2019 inspection. There are no data integrity observations.

“The company will work closely with the USFDA and is committed to addressing these within the stipulated time, the company said in a filing with BSE.

Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.

Cipla primarily develops medicines to treat respiratory and cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.

UFDA issues Form 483 to Cipla’s facility in MP

USFDA issues Form 483 with 6 observations to Sun Pharma

USFDA issues Form 483 for 4 observations to Zydus

USFDA completes inspection at Stride Pharma with zero observation

USFDA issues Form 483 for 6 observations to Jubilant Pharmova

USFDA issues Form 483 for 3 observations to Aurobindo Pharma

Penalty provision for Blood Banks / Centres not updating stock in time

Govt invites eligible Medical Devices Firms Category B of PLI scheme

Drug Rules 1945 amended to allow parallel submission of manufacturing & marketing approvals

USFDA gives approval for this Contraceptive

This Air is an essential element for the Tablet Coating Process

USFDA gives nod for Formoterol Fumarate inhalation solution

NPPA fixes Retail Prices of 45 drug formulations

CDSCO panel wants justification on Protocol Amendments on Trail of Imlunestrant

USFDA gives nod for generic Carbamazepine tablets

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