USFDA issues Form 483 to Alembic Pharma Gujarat plant

Alembic Pharma gets Form 483 from USFDA

Picture: Pixabay

Last Updated on December 18, 2021 by The Health Master

US Food and Drug Administration (USFDA) issued a Form 483 for Alembic Pharma’s Karkahadi plant in Gujarat.

10 observations on Form 483 issued by the US regulator after its inspection at Alembic Pharma from October 28-November 10.

The regulator largely observed that the plant had not established control procedures and processes with respect to cleaning and maintenance were inadequate.

The USFDA also said the procedures to prevent microbiological contamination were inadequate and that the plant did not maintain written records of investigations into unexplained discrepancies.

FDA Haryana and police unearthed a unit manufacturing spurious cosmetics

In-service Pharmacists authorised to dispense drugs for these 8 common ailments

Recruitment of 87 Drug Inspectors put on hold in Maharashtra

Indian Pharma Industry can meet requirements of the World

10th Gujarat Global Summit 2022 will be held from 10-12 January…

NPPA fixes retail price of Torrent’s FDC Atorvastatin, Clopidogrel Bisulphate, Aspirin

NDPS: 9 arrested for selling drugs

Drug recall: Lupin recalls 4,113 cartons of oral contraceptive

Procedure for registration of Medical Devices: CDSCO

Latest Notifications regarding Pharmaceuticals

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

YouTube Icon
YouTube Icon

Enter your email address:

Delivered by FeedBurner