Last Updated on October 6, 2024 by The Health Master
The United States Food and Drug Administration (USFDA) has made eleven observations following a recent inspection of Ipca Laboratories’ active pharmaceutical ingredients (API) manufacturing facility in Ratlam (Madhya Pradesh).
The USFDA inspection was held from June 5 to 13, 2023, it said. “At the conclusion of the inspection, the USFDA issued a Form 483 with 11 (eleven) observations.”
The company will submit a “comprehensive response” on these observations to the USFDA in the stipulated time and shall work closely with the agency to resolve the issues at the earliest, it told the stock exchange.
Earlier this month, Ipca said the Income Tax Department had conducted survey proceedings at its Mumbai offices and manufacturing plants in Sikkim, between May 30, 2023, and June 3, 2023.
Ipca recently acquired a 33 per cent stake in Unichem for ₹1,034 crore, a buy that drew sharp observations from some sections of the analyst community.
The company has also been dealing with multiple manufacturing-linked issues involving the United States regulatory authority.
USFDA issues Form 483 with 4 observations to Aurobindo Pharma
USFDA issues Form 483 with zero observations to Pharma MSMEs: Gujarat
USFDA issues Form 483 with 3 observation to Zydus, Ahmedabad
USFDA issues Form 483 with zero observation to Piramal
USFDA issues Form 483 with 10 observations to Lupin, Pithampur
USFDA issues Form 483 with 2 observations to Alembic, Gujarat
USFDA gives approval for Metoprolol Succinate ER Tablets
UP Govt Drafts Pharmaceutical Industry Policy 2023: Details
CDSCO implements transparent reporting system for Cough Syrup exports
Safe Disposal of Unused Drugs: Urgent Need a Comprehensive Policy
PLI Schemes Drive Rs. 21,861 crore in investments for Pharmaceuticals and Medical Devices
Drug alert: 28 out of 1302 samples declared as NSQ in May 2023
Action to be taken against Pharmacies offering abnormal discounts: Karnataka
NPPA Guidelines: For change of Manufacturer in Notified Drug Formulations
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:
