Last Updated on October 9, 2024 by The Health Master
New Delhi: Drug maker Lupin said the US health regulator has issued Form 483 with eight observations each for product and raw material production centers at its Mandideep-based manufacturing facility.
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 may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts.
The USFDA had inspected the Mandideep Unit-1 facility in Madhya Pradesh from November 14, 2022, to November 23, 2022, the Mumbai-based drug maker said in a regulatory filing.
“The inspection of the facility closed with the issuance of Form 483, with eight observations each for the drug product facility and active pharmaceutical ingredient (API) facility at the site,” it added.
The company is committed to addressing the observations and will work with the US health regulator to resolve the issues at the earliest, Lupin said.
Lupin announced that the US health regulator has issued Form 483 with five observations, following a pre-approval inspection of its Unit-2 injectable manufacturing facility at Nagpur.
Shares of Lupin closed 0.11 percent down at Rs 718 apiece on the BSE.
USFDA issues Form 483 with 10 observations to Aurobindo Pharma
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
Drug recall: FDA issues nationwide recall for Ferric Carboxymaltose
Govt issues draft notification to amend NDCTR, 2019
Haryana: Sathi app launched to check Drugs abuse
CDSCO approves 4 more Medical Device Testing Labs (MDTL)
Antitrust litigation filed against Dr Reddy’s Lab and others
GSK to stop selling this Blood Cancer drug
USFDA gives nod for Nifedipine ER tablets
NPPA: No bar on taking corrective measures if some error occurs
RIICO to develop Medical Devices Park
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:
