Last Updated on January 5, 2024 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:
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:
