Last Updated on October 10, 2024 by The Health Master
New Delhi: Drug major Cipla said the US Food and Drug Administration (USFDA) has classified its Goa plant as ‘Official Action Indicated’ (OAI), impacting product approvals from the facility meant for the US market.
According to the USFDA definition, “Official Action Indicated” (OAI) means “objectionable conditions were found and regulatory administrative sanctions by the FDA are indicated” during inspections.
It states that a USFDA inspection revealed significant objectionable conditions or practices, and action must be taken to address the issues.
“We wish to inform you that the company has received a communication from the USFDA that the classification of the company’s said facility continues to be OAI,” Cipla said in a regulatory filing.
The USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved, it added.
The company has an ongoing de-risking plan in place for new product approvals, the Mumbai-based drug major said.
Cipla will work closely with the USFDA and is committed to addressing these within the stipulated time, it added.
The USFDA inspected the company’s Goa plant in August this year.
Warning for use of Antibiotics for low-grade fever: ICMR guidelines
USFDA declines to approve this Lung Cancer drug
NPPA fixes Retail Price of 40 formulations: November 2022
IPC adds one IP Reference Standard & 20 new impurities to IP 2022
USFDA issues warning letter to Glenmark’s Goa facility
DCGI gives nod to Intranasal C-19 booster dose
USFDA issues Form 483 with 8 observations to Lupin
Govt issues draft notification to amend NDCTR, 2019
Haryana: Sathi app launched to check Drugs abuse
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:
