FDA 483 - Aurobindo Pharma USA Inc - May 13, 2024

The FDA inspected Aurobindo Pharma USA Inc."s corporate headquarters from May 13-15, 2024, uncovering critical non-compliance with the Drug Supply Chain Security Act (DSCSA). The primary issues observed included a systemic failure to implement robust procedures and systems for verifying product legitimacy and managing supply chain security. Specifically, the company"s written procedures were inadequate for identifying suspect products, conducting investigations with trading partners, validating transaction information, and ensuring timely notifications (within 24 hours) to the FDA regarding suspect, illegitimate, or high-risk products, as required by the DSCSA. Furthermore, Aurobindo Pharma lacked established systems to respond to notifications of illegitimate products from the FDA or trading partners, or to handle requests for product identifier verification. A significant violation involved the company"s failure to notify the FDA within 24 hours of a cargo theft on May 31, 2023, involving prescription drug products, which are considered illegitimate under the DSCSA. To achieve compliance, Aurobindo Pharma is required to develop and implement comprehensive systems and update their standard operating procedures to align with federal drug supply chain security regulations, ensuring proper investigation, notification, and response protocols.