Last Updated on December 31, 2023 by The Health Master
Aurobindo Pharma
Pharmaceutical leader Aurobindo Pharma achieves a significant milestone with the USFDA’s Voluntary Action Indicated classification for Unit III in Bachupally Village, Telangana.
Aurobindo Pharma, a prominent player in the pharmaceutical industry, recently received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Unit III located in Bachupally Village, Telangana.
This marks a significant achievement for the company, solidifying its commitment to quality and compliance.
USFDA Inspection Details
The USFDA conducted a comprehensive inspection of Aurobindo Pharma Limited’s Unit III in Bachupally Village, Telangana, spanning from July 14 to July 21.
The inspection aimed to assess the facility’s adherence to stringent regulatory standards.
Observations and Form 483
On July 21, the USFDA issued Form 483, which contained three observations for the mentioned unit.
It’s important to note that a Form 483 is a document issued to a firm’s management at the conclusion of an inspection, listing any conditions that may constitute violations of the Food, Drug, and Cosmetic Act.
Voluntary Action Indicated (VAI) Status
Despite the observations, the USFDA classified Unit III as Voluntary Action Indicated (VAI).
This designation signifies that while noteworthy deficiencies were identified during the inspection, they do not necessitate immediate regulatory action.
This status is a positive outcome, allowing the company to continue its operations without interruption.
Implications of VAI Status
The VAI classification empowers Aurobindo Pharma to pursue approvals for new drugs from this particular facility.
Additionally, it grants the company the ability to continue the production and commercialization of previously approved medications.
This designation holds substantial significance, as it represents the second-highest classification attainable by a pharmaceutical manufacturing facility under the scrutiny of the USFDA.
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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