USFDA issues warning letter to Glenmark’s Goa facility

"The Company is committed to working along with the USFDA to implement all the necessary corrective actions required to address the concerns at the earliest."

371
Warning, FDA
Picture: Pixabay

Last Updated on November 26, 2022 by The Health Master

The drugmaker Glenmark said it does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from the operations of this facility.

The US Food and Drug Administration (USFDA) inspected Glenmark’s Goa facility in May 2022 and issued an Official Action Indicated (OAI).

The drug regulator has now issued a warning letter to the Goa facility.

“The company is committed to working with the USFDA to implement all necessary corrective actions as soon as possible to address the concerns.”

“The company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe,” Glenmark said in a statement.

Glenmark Pharmaceuticals is primarily engaged in the business of the development, manufacture, and marketing of pharmaceutical products.

USFDA issues warning letter to Lupin

USFDA issues warning letter to Lupin API plant

USFDA issues warning letter to Aurobindo Pharma for manufacturing lapses at API plant

USFDA gives warning letter to Aurobindo Pharma for API facility

Lupin gets warning letter from USFDA for Somerset facility

USFDA issues warning to Shilpa Medicare for cGMP violations

DCGI gives nod to Intranasal C-19 booster dose

USFDA issues Form 483 with 8 observations to Lupin

Drug recall: FDA issues nationwide recall for Ferric Carboxymaltose

Govt issues draft notification to amend NDCTR, 2019

Haryana: Sathi app launched to check Drugs abuse

CDSCO approves 4 more Medical Device Testing Labs (MDTL)

Antitrust litigation filed against Dr Reddy’s Lab and others

GSK to stop selling this Blood Cancer drug

USFDA gives nod for Nifedipine ER 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
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news