Last Updated on October 2, 2024 by The Health Master
Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) has issued Form 483 with 10 observations after the inspection of its Unit IX, Gundlamachnoor facility.
The drugmaker said that Unit IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, had been classified as OAI (official action indicated) on May 17, 2019, and the company had responded to the agency and carried out the required corrective actions.
The US drug regulator reinspected the facility from November 10 to 18, 2022.
At the end of the inspection, the pharmaceutical company was issued a Form 483, with 10 observations.
The observation is procedural in nature and not related to data integrity, the pharma company stated.
The pharma major added that it will respond to the USFDA, within the stipulated timeline and will work closely with the agency to address the observations at the earliest.
Aurobindo Pharma develops, manufactures, and distributes generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients.
The pharmaceutical company reported a 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.
Shares of Aurobindo Pharma were down 1.13% to Rs 468.75 on Friday, November 18, 2022.
USFDA issues Form 483 with 3 Observations to Alkem
USFDA issues Form 483 with 5 observations to Lupin
USFDA issues Form 483 with one Observation to Laurus Labs
USFDA issues form 483 with 17 observations to Lupin
USFDA issues form 483 with four observations to Alembic Pharma
USFDA issues 2 observations on Form 483 to Zydus Lifesciences
USFDA gives approval for Potassium-deficiency drug
Govt starts drive against misuse of Antibiotics
Bar code or QR code for 300 brands: Govt notifies these drugs under Schedule H2
USFDA gives EIR to Aurobindo Pharma for its AP facility
Maha FDA to take action against bodybuilders involved in misuse of prescription drugs
Altering the contents of formulation without changing brand names
Dr VG Somani gets another three-month extension for his post as DCGI
Govt dissolves Odisha State Pharmacy Council
First EC meeting of DCOIWA held at pink city Jaipur
Latest Notifications regarding Pharmaceuticals
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:
