Last Updated on December 31, 2023 by The Health Master
The pre-approval inspection of Aurobindo Pharma was carried out from 8 February 2022 to 15 February 2022. On completion of the inspection, the USFDA issued Form 483 with five observations.
Based on the inspection review and the written responses given by the company, the United States Food and Drug Administration (USFDA) concluded that the assessment was completed with no remaining deficiencies, Aurobindo said in a press.
A copy of the Establishment Inspection Report (EIR) has been received by the company dated 17 May 2022.
Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.
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