USFDA issues Form 483 with 6 observations to Sun Pharma

The Company is preparing the response to the observations, which will be submitted to USFDA within the stipulated timeline., the company said.

1816
USFDA Inspection audit Form 483
USFDA Form 483

Last Updated on December 31, 2023 by The Health Master

Sun Pharmaceuticals Industries Limited has updated on U.S. Food and Drugs Administration (USFDA) Inspection at Mohali Facility.

As per the filing, the USFDA has conducted an inspection of the Mohali manufacturing facility (Punjab, India) of Sun Pharmaceutical Industries from August 3, 2022, to August 12, 2022.

At the conclusion of the inspection, the USFDA issued a Form-483, with 6 observations. 

The Company is preparing the response to the observations, which will be submitted to USFDA within the stipulated timeline., the company said.

It further added, “The Company is committed to addressing these observations promptly. The Company remains committed to working closely with the USFDA and continues to enhance its compliance on an ongoing basis.”

USFDA issues Form 483 for 4 observations to Zydus

USFDA completes inspection at Stride Pharma with zero observation

USFDA issues Form 483 for 6 observations to Jubilant Pharmova

USFDA issues Form 483 for 3 observations to Aurobindo Pharma

USFDA completes inspection of Casper Pharma with Zero Observations

USFDA issues Form 483 for six observations to Granules Pharma

Anti-dumping duty recommended on Ofloxacin & its intermediates imported from China

USFDA gives nod for generic Naproxen Sodium Softgel Capsules

IPC clarifies: General Chapter on ‘Uniformity of Dosage Units’ in IP 2022 not mandatory

USFDA gives approval for Rufinamide tablets

IPC adds 5 new IP Reference Standards & 7 new Impurities…

HP: Pharma units, Wholesalers, Chemist Shops under scanner of Anti Narcotic…

Dr VG Somani to continue as DCGI for next three months

Drug alert: 53 out of 1337 samples declared as NSQ in July 2022

20 Blood Banks fined ₹2.3cr for overcharging

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

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