USFDA issues Form 483 for 3 observations to Aurobindo Pharma

At the end of the inspection, the firm have been issued a Form 483 with three observations and none of these observations are related to data integrity

194
USFDA Form 483

Last Updated on August 4, 2022 by The Health Master

Aurobindo Pharma said the US health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh.

As per the US Food and Drug Administration (USFDA), 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 Pydibhimavaram unit was classified as OAI (official action indicated) on May 17, 2019, and subsequently given a warning letter on June 20, 2019, by the USFDA, Aurobindo Pharma said in a regulatory filing.

Subsequently, the company said it has responded to the warning letter and carried out the committed corrections, and the USFDA authorities inspected the facility from July 25 to August 2, 2022.

“At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related to data integrity,” Aurobindo Pharma said.

The company will respond to the USFDA within the stipulated timeline and work closely with the regulator to address the observations at the earliest, it added.

The unit is a non-antibiotic active pharmaceutical ingredient manufacturing facility.

USFDA completes inspection of Casper Pharma with Zero Observations

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

Govt releases new National Standards for Blood Centres and Blood Transfusion

Drug prices: What is One-molecule, One-price policy ?

USFDA completes inspection of Casper Pharma with Zero Observations

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

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