Sagent Pharmaceuticals, Inc.
FDA issued a warning letter to Sagent Pharmaceuticals, Inc. (SterRx, LLC) following a September–November 2021 inspection of its 503B outsourcing facility in Plattsburgh, NY, finding serious CGMP deficiencies in sterile drug manufacturing, including inadequate first-air protection, turbulent ISO 5 airflow, microbial contamination failures, dirty equipment, and improper sterilization practices. These deficiencies caused drug products to be adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FDCA. The firm had already voluntarily ceased aseptic production, initiated a voluntary recall of sterile lots, and destroyed in-process inventory, but FDA found corrective action responses inadequate due to missing supporting documentation. FDA warned that failure to adequately address violations may result in seizure or injunction, and required a written response within 15 working days.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of drugs intended or expected to be sterile.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. We also recommend a third-party consultant with relevant sterile drug manufacturing expertise to assist you in conducting this comprehensive evaluation.
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