Aurobindo Pharma USA Inc., a 100% subsidiary of Aurobindo Pharma, recently underwent an inspection by the United States Food and Drug Administration (US FDA) at its East Windsor, New Jersey, warehouse. The inspection, conducted from May 13 to May 15, 2024, focused on compliance with the Drug Supply Chain Security Act (DSCSA).
Following the inspection, the US FDA issued five observations and classified the facility’s inspection status as “Official Action Indicated (OAI).” This designation means that the agency has identified certain areas requiring corrective action.
Despite this classification, Aurobindo Pharma USA does not anticipate any immediate business impact. The company remains committed to working closely with the US FDA to address concerns and further strengthen compliance measures.
In the meantime, on February 7, the company announced that its API manufacturing Unit 2 in Gaddapotharam Village, Telangana, has been classified as “Voluntary Action Indicated” (VAI) by the US FDA. This follows an inspection conducted from September 23 to 27, 2024, and the issuance of an Establishment Inspection Report (EIR) on January 28, 2025. The VAI classification confirms that no further regulatory action is needed. The inspection initially resulted in Form 483 with 10 procedural observations, all of which were successfully addressed.
