The United States Food and Drug Administration (USFDA) concluded an inspection at one of the warehouses of Aurobindo Pharma USA Inc, a 100 per cent subsidiary of Aurobindo Pharma, situated at East Windsor, New Jersey, with five observations.
According to the Hyderabad-based Aurobindo Pharma, the inspection was conducted from May 13, 2024, to May 15, 2024, with regards to compliance of the Drug Supply Chain Security Act (DSCSA).
“The inspection concluded with 5 observations. Subsequently, the USFDA has determined the inspection classification status of this warehousing facility as ‘Official Action Indicated (OAI)’. At this point in time, the Company doesn’t foresee any impact on the business,’‘ the drug-maker said in a disclosure to the BSE.
“The Company remains committed to work closely with the USFDA and continues to enhance its compliance on an ongoing basis,’‘ it added.