Last Updated on August 14, 2024 by The Health Master
OAI Classification
OAI Classification: Aurobindo Pharma is facing regulatory headwinds after the US Food and Drug Administration (USFDA) issued a stern warning to its subsidiary, Eugia Pharma Specialities Ltd.
The regulatory body has classified the Unit II formulation manufacturing facility located in Bhiwadi, Alwar, Rajasthan as ‘Official Action Indicated (OAI)’. This is a serious setback for the Indian pharmaceutical giant.
Inspection Findings Lead to Severe Warning
The USFDA conducted a thorough inspection of the facility between April 25th and May 3rd, 2024.
The outcome of this inspection was far from satisfactory, with the agency identifying a total of 7 observations.
These findings were deemed severe enough to warrant the OAI classification.
What does OAI mean?
An OAI classification is a serious regulatory action that indicates significant deficiencies in a manufacturing facility.
It suggests that the facility has failed to meet regulatory or administrative requirements and may pose a risk to public health.
Consequently, the company can expect further regulatory scrutiny and potential restrictions.
Aurobindo Vows to Address Issues
In response to the USFDA’s action, Aurobindo Pharma has expressed its commitment to working closely with the regulatory agency to rectify the identified issues.
The company has pledged to enhance its compliance practices to prevent similar occurrences in the future.
Aurobindo Pharma
Aurobindo Pharma is a prominent player in the global pharmaceutical industry, with a strong presence in over 150 countries.
The company boasts a vast product portfolio spanning critical therapeutic areas like CNS, HIV/AIDS, cardiovascular diseases, antibiotics, and more.
With a robust R&D infrastructure and state-of-the-art manufacturing facilities, Aurobindo has earned a reputation for quality and innovation.
However, the recent OAI classification is a significant challenge that the company must address promptly to safeguard its reputation and market position.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
USFDA issues Form 483 with 3 observations to Gland Pharma
USFDA issues Form 483 with 2 observations to Gland Pharma
Zydus receives favorable outcome After USFDA Inspection
USFDA inspection concluded at Divi’s Labs with one observation
Indian Pharma industry urges NPPA for stable drug pricing policy
IPHEX 2024: Your Gateway to Indian Pharma Market
Indian Govt implements Pharma PLI scheme worth Rs 15,000 Cr
USFDA issues Form 483 with 3 observations to Gland Pharma
Imports of Bulk Drugs from China grew 8.8 %
CDSCO approval granted for Beyfortus in India
Human Error: The Silent Killer of the Indian Pharma Industry
Drug Recall in India: A Growing Concern
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:
