FDA EIR - Genesis BPS, LLC. - June 11, 2013

An FDA inspection of Genesis BPS, LLC., a Class I and II medical device firm in Hackensack, NJ, was conducted from February 4-11, 2013. The inspection, guided by the Quality System Inspection Technique (QSIT), focused on management and design controls, and corrective and preventive actions (CAPA), as well as compliance with corrections and removals regulations (21 CFR Part 806) and purchasing controls. The primary violation, documented in an FDA Form 483, was the company's failure to complete a thorough risk assessment for its Pedi-Pak® Pedi-Syringe Filter™ 30 mL & 60 mL device. This included not quantifying potential hazards by evaluating likelihood, severity, and detection to ensure risks were mitigated to acceptable levels, as required by design control regulations (21 CFR 820.30(g)). Verbal observations also highlighted inadequate follow-ups for root cause determination in customer complaints and the absence of a clear ranking system for issue severity within the CAPA procedure. Genesis BPS, LLC. committed to implementing corrections for the FDA 483 observation, including establishing a quantifiable risk assessment tool, and promised an initial written response within 15 days, with a final response within 90 days. Management also agreed to revise the complaint handling and CAPA procedures to address the noted deficiencies.