FDA EIR - Par Sterile Products, LLC - April 15, 2019

An FDA inspection of PAR Sterile Products LLC, a sterile drug manufacturer located in Rochester, MI, was conducted from April 8 to April 15, 2019. This comprehensive surveillance inspection, carried out under current Good Manufacturing Practices (cGMP), identified significant issues primarily concerning record-keeping and procedural adherence. The main violation, formalized in an FDA Form 483, highlighted deficiencies in batch production and control records. Specifically, the firm failed to adequately document significant manufacturing steps, including the contemporaneous verification of rejected vial counts and timely signatures for completed activities. The report noted instances where supporting documents lacked specific, relevant information, thereby not fully substantiating critical entries. This finding referenced 21 CFR 211.188(b) regarding general requirements for batch production and control records. Beyond the formal observation, the inspection included verbal discussions with management on several other concerns. These covered aspects of complaint handling, the methodology for Acceptance Quality Limit (AQL) sampling for small batch sizes, and the process for sampling incoming Active Pharmaceutical Ingredients (API). The report also noted an issue with the robustness of the Argatroban assay method and the firm's policy of only conducting visual inspections on returned product samples, which could impede comprehensive root cause investigations. In response to the FDA 483, PAR Sterile Products LLC management committed to submitting a written reply within 15 business days addressing the identified deficiencies.