Last Updated on October 9, 2024 by The Health Master
Mumbai: Indian multinational pharmaceutical company, Alkem Labs, has recently announced that the company has received Form 483 with three (3) observations from the US Food and Drug Administration (USFDA) at the end of the pre-approval inspection of its St. Louis facility.
A 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.
“This is to inform you that USFDA conducted a pre-approval inspection at the company’s manufacturing facility located in St. Louis, USA, from October 31st, 2022, to November 9th, 2022,” the company stated in a BSE filing.
There is no data integrity observation. This pre-approval inspection is part of routine business operations, and the company shall submit to USFDA, within the stipulated timeline, a detailed response to close out the said observations.
USFDA issues Form 483 with 5 observations to Lupin
USFDA issues Form 483 with one Observation to Laurus Labs
USFDA issues form 483 with 17 observations to Lupin
USFDA issues form 483 with four observations to Alembic Pharma
USFDA issues 2 observations on Form 483 to Zydus Lifesciences
USFDA issues Form 483 to Indoco with zero observation
Injections for Diabetes, Cancer could become unnecessary soon
USFDA gives nod to market this generic Antibiotic Drug
USFDA issued OAI Status to Sun Pharma
Pharmacy Inspectors to be appointed soon
PCI clarifies its decision to restore admission intakes
Drug recall: These drugs recalled by Aurobindo for this reason
Lab-made Blood given to people in world-first Clinical Trial
USFDA gives tentative approval for Drospirenone tablets
IPC adds 10 new Impurity Reference Substances to IP 2022
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
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:
