Last Updated on December 31, 2023 by The Health Master
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:
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:
