USFDA completes inspection of Casper Pharma with Zero Observations

The audit is part of the agency's inspection of three product applications filed and slated to be manufactured at this site.

131
USFDA
Picture: Pixabay

Last Updated on August 3, 2022 by The Health Master

Hyderabad: Suven Pharmaceuticals Ltd has announced that the US Food and Drug Administration (USFDA) has completed a pre-approval inspection at the Casper Pharma Private Limited formulations manufacturing facility situated at GMR Hyderabad SEZ, a wholly owned subsidiary of Suven Pharmaceuticals Limited in Hyderabad, India.

The inspection was conducted from July 25th through July 29th, 2022.

The audit is part of the agency’s inspection of three product applications filed and slated to be manufactured at this site.

According to Venkat Jasti, Managing Director of Suven Pharmaceuticals Limited, “We are happy to have completed the audit successfully with Zero observations and at the end of the inspection, no form 483 was issued by USFDA which signifies compliance and conformance to applicable cGMP regulations.”

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

Seven Pharmaceuticals Limited, a company incorporated in November 2018, has become a Wholly Owned Subsidiary of Suven Life Sciences Limited, effective February 2019.

USFDA issues Form 483 for six observations to Granules Pharma

USFDA issues Form 483 for 3 observations to Biocon for Telangana plant

USFDA issues 2 observations to Cipla Indore Plant

USFDA issues 6 observations to Glenmark Baddi Facility

USFDA issues 8 Observations to Panacea Biotec for Baddi Facility

USFDA gives 5 observations to Glenmark Pharma for Goa facility

AYUSH doctors can practise allopathy with own system: High Court

7,700 drug samples declared not of standard quality

USFDA gives nod for Diclofenac Sodium Topical Gel

USFDA gives nod for generic birth control pills

New technology that deactivates COVID-19 virus in just 1 minute

Foreign MBBS holders: Registration only after 2 Years internship: NMC

USFDA gives nod for Belimumab to treat Paediatric Patients

CDSCO issues alert on Blood Purification Device hemoperfusion cartridge

CDSCO gives nod to make generic version of Pfizer’s Covid-19 pill

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