Last Updated on December 28, 2023 by The Health Master
I. EIR
Aurobindo Pharma recently made headlines as the U.S. Food and Drug Administration (USFDA) issued an Establishment Inspection Report (EIR) for Unit IV of APL Healthcare Limited, a wholly-owned subsidiary of the company, located in Andhra Pradesh.
This report categorized the inspection outcome as ‘voluntary action indicated‘ (VAI).
II. USFDA Inspection
The USFDA conducted a thorough inspection of Unit IV from September 13 to September 19, 2023, focusing on the formulation manufacturing facility situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh.
III. Establishment Inspection Report (EIR)
The term ‘Voluntary Action Indicated‘ (VAI) implies that while objectionable conditions or practices were identified during the inspection and issuing an Establishment Inspection Report (EIR), the USFDA has chosen not to take immediate regulatory action.
IV. Form 483 and Observation
At the conclusion of the inspection, the FDA issued a ‘Form 483,’ outlining one observation related to the facility’s operations. This raises questions about the nature of the observation and its potential impact.
V. Aurobindo’s Response
In response to the inspection outcome, Aurobindo Pharma released a statement through a BSE filing, acknowledging the receipt of the Establishment Inspection Report and clarifying the facility’s classification as “Voluntary Action Indicated.”
VI. APL Healthcare Limited
Aurobindo’s wholly-owned subsidiary, APL Healthcare Limited, is under scrutiny due to the recent inspection. Understanding the role and significance of this subsidiary adds depth to the unfolding story.
VII. Unit IV Facility
The manufacturing facility in question, Unit IV, plays a pivotal role in Aurobindo’s operations. Delving into its location and the type of formulations manufactured provides context to the inspection’s implications.
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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