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Sagent Pharmaceuticals' outsourcing facility was cited for serious deficiencies in manufacturing practices for sterile drug products that violated Current Good Manufacturing Practice (CGMP) regulations and put patients at risk. FDA inspectors identified critical failures in the facility's aseptic processing procedures during a September-November 2021 inspection, leading the company to voluntarily cease production of all aseptically processed products in October 2021 and initiate a recall of approximately (b)(4) lots of sterile drug products lacking sterility assurance. The company subsequently committed to destroying in-process lots and notified FDA of its intent to resume sterile product distribution after implementing corrective measures.