USFDA issues form 483 with four observations to Alembic Pharma

The USFDA had conducted an inspection at the facility located at Panelav from 4th to 14th October, 2022

687
USFDA Form 483
USFDA Form 483

Last Updated on October 9, 2024 by The Health Master

Alembic Pharma today said the U.S. Food and Drug Administration (USFDA) has issued a Form 483 with four procedural observations after an inspection of its oncology injectable formulation facility at Panelav in Gujarat.

The USFDA conducted an inspection at the facility located at Panelav from October 4th to October 14th, 2022, Alembic Pharma said in a regulatory filing.

“The USFDA issued a Form 483 with four procedural observations.”

None of the observations is related to data integrity, and management believes that they are addressable,” it added.

USFDA issues 2 observations on Form 483 to Zydus Lifesciences

USFDA issues Form 483 to Indoco with zero observation

USFDA issues Form 483 with 11 observation to Biocon

USFDA issues Form 483 with 2 observation to Alembic

USFDA issues Form 483 with one observation to Aurobindo Pharma subsidiary’s plant

USFDA issues Form 483 with 6 observations to Cipla

Govt brings these eight substances under NDPS Act

USFDA gives tentative approval for Valbenazine capsules

CDSCO Panel gives nod to study Anti Allergic Combination Drug

DCGI notifies classification of 48 Medical Devices related to Oncology under MDR 2017

CDSCO Panel gives nod to study Elagolix Tablet

Procedure to obtain registration for Blood Storage Centre

DTAB seeks report on FDCs related to vitamins, minerals formulations from Kokate Committee

USFDA gives nod for Extended Phenytoin Sodium Capsules

DCGI notifies classification of 95 Medical Devices related to dental healthcare under MDR, 2017

Latest Notifications regarding Pharmaceuticals

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