Last Updated on January 4, 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.
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