Drugs

FDA Cites Aurobindo for Drug Supply Security Lapses

FDA has cited Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including delays in reporting stolen prescription drugs to the agency, according to a just-posted FDA Form 483. The inspection report was issued following a 2024 inspection and is just now being released.

The FDA 483 followed a three-day inspection of Aurobindo’s corporate headquarters in East Windsor, NJ. The inspection focused on the company’s compliance with the Drug Supply Chain Security Act (DSCSA), which requires manufacturers and other trading partners to detect, investigate and promptly report suspect or illegitimate drug products.

In its first observation, FDA said Aurobindo lacked adequate systems and procedures to meet DSCSA verification and notification requirements. Investigators found that several written procedures failed to describe how the company identifies suspect products, conducts investigations with trading partners, validates transaction histories, or determines whether a product is illegitimate.

The agency also faulted Aurobindo’s procedures for failing to ensure that FDA and immediate trading partners are notified within 24 hours when a product is determined to be illegitimate or at high risk for illegitimacy, as required by law. In addition, the agency said the company did not have adequate processes to respond to verification requests from the agency or other authorized trading partners, nor systems to investigate illegitimate products after receiving notifications from FDA or supply chain partners.

A second observation cited a specific instance in which Aurobindo failed to notify FDA within the required 24-hour window after determining that prescription drugs in its control were illegitimate. According to the inspection report, the company was alerted on May 31, 2023, to a cargo theft involving prescription drug products under its control. Under the DSCSA, products with credible evidence of theft are considered illegitimate. FDA said Aurobindo did not submit an illegitimate product notification to the agency within 24 hours of becoming aware of the theft.

The remaining inspection findings were heavily redacted.

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