Last Updated on September 13, 2023 by The Health Master
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 inspection aimed to assess the facility’s adherence to stringent regulatory standards.
Observations and Form 483
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
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
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.
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