Last Updated on December 22, 2024 by The Health Master
Form 483 with one observation
Form 483: Aurobindo Pharma, a prominent player in the pharmaceutical industry, recently underwent an inspection by the U.S. Food and Drug Administration (USFDA) at its formulation manufacturing unit located in Telangana’s Sangareddy district.
This inspection, conducted from September 22nd to 29th, resulted in the issuance of a Form 483, accompanied by a single observation.
In this article, we delve into the details of this inspection, its implications, and Aurobindo Pharma’s response.
Understanding Form 483: A Regulatory Insight
Form 483: The USFDA’s Observations
The issuance of a Form 483 by the USFDA signifies that the agency’s investigators have identified conditions during their inspection that may potentially contravene the Food Drug and Cosmetic Act and related Acts.
It serves as a vital communication tool between the USFDA and the inspected entity, providing a documented account of the observed irregularities.
Procedural Nature of the Observation
Aurobindo Pharma has reported that the observation made by the USFDA is procedural in nature.
This suggests that it pertains to processes or protocols rather than critical product quality issues.
This distinction is crucial, as procedural observations generally entail adjustments to internal operational practices rather than major overhauls.
Aurobindo Pharma’s Response: Timely and Committed
Meeting Timelines: Aurobindo’s Pledge
Aurobindo Pharma has assured stakeholders that it is dedicated to addressing the observation within the specified timelines.
This commitment underscores the company’s adherence to regulatory compliance and its proactive approach towards rectifying any identified issues.
Prior Inspections: A Recap
APL Healthcare Facility Inspection
Earlier this month, Aurobindo Pharma’s wholly owned subsidiary, APL Healthcare, faced a similar situation.
The USFDA issued a Form 483 with a single observation following an inspection of its formulation manufacturing facility in Naidupeta mandal of Tirupati district, Andhra Pradesh.
This dual occurrence within a short span underscores the scrutiny that pharmaceutical facilities undergo to ensure compliance with stringent regulatory standards.
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 gives positive Inspection Report to Lupin: Nagpur
USFDA’s New Inspection Approach for India’s Pharmaceutical Industry
USFDA Inspection Process: A Closer Look at Divi’s Laboratories
USFDA issued Positive EIR to Gland Pharma: Hyderabad
USFDA issues warning letter to Fresenius Kabi: Read detail
Amendment in D&C Act: Decriminalizing Offences for Trust-Based Governance
USFDA gives positive Inspection Report to Lupin: Nagpur
Drug recall: Ibrexafungerp tablets recalled due to cross contamination
USFDA’s New Inspection Approach for India’s Pharmaceutical Industry
Regulatory Practices: Gujarat FDCA Collaborates with USFDA for Strengthening
GMP Compliance for MSME Pharma Companies: Challenges and Perspectives
Govt issues draft notification for inclusion of Oseltamivir and Zanamivir in Schedule H1
Empowering Teens: New Contraceptive Implant to Combat Teenage Pregnancy
Anti-TB Drugs: Urgent appeal to address critical shortage in India
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:
