USFDA gives 10 observations to Sun Pharm

The company is committed to addressing the observations promptly, Sun Pharma noted.

305
USFDA
Picture: Pixabay

New Delhi: Sun Pharma said the US health regulator has issued a ‘Form 483’ with ten observations after inspecting its Halol-based manufacturing plant in Gujarat.

As per USFDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The US Food and Drug Administration conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, 2022, the Mumbai-based drug maker said in a regulatory filing.

“At the conclusion of the inspection, USFDA issued a Form-483, with 10 observations. The company is preparing the response to the observations, which will be submitted to USFDA within 15 business days,” it added.

The company is committed to addressing the observations promptly, Sun Pharma noted.

It remains committed to working closely with USFDA and continues to enhance its GMP compliance on an ongoing basis, it added.

USFDA gives Zero Observations to SMS Lifesciences

USFDA issues 4 Observations to Lupin for Tarapur Facility

USFDA gives 13 observations to Lupin

USFDA complete audit of Granules Pharmaceuticals with 3 observations

USFDA issues 3 observations on Zydus manufacturing unit

USFDA issues 3 observations to Granules Pharmaceuticals Inc

FAQs – on Blood Bags and its Testing

USFDA gives tentative nod to Glenmark for Calcipotriene and Betamethasone Dipropionate foam

IPC releases IP 2022, 92 new monograph, 27 APIs added: Read details

USFDA gives tentative approval for this Hypertension drug

Man held in Internet pharmacy racket, Rs 3.17 cr cash seized

Man gets 10-years rigorous imprisonment for making drugs illegally

USFDA gives tentative nod to Zydus for Selexipag tablets

Govt releases guidelines on Pharma innovation and entrepreneurship for academic institutions

USFDA gives approval to Lupin Pregabalin capsules

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

Enter your email address:

Delivered by FeedBurner