FDA 483 - JAS Diagnostics, Inc./Drew Scientific, Inc. - August 29, 2019

During an FDA inspection from August 15-29, 2019, medical device manufacturer JAS Diagnostics/Drew Scientific, Inc./Diamedix Corp. received a Form FDA 483 detailing significant quality system deficiencies. The firm was cited for an inadequately established and maintained organizational structure, failing to allocate sufficient resources to ensure devices conform to 21 CFR 820. This included incomplete corrections from prior 2014 and 2016 inspections, premature closure of corrective actions and complaint investigations, and an untrained Management Representative. Repeat observations from previous inspections highlighted systemic issues. The company lacked adequate procedures for corrective and preventive actions, specifically failing to conduct thorough root cause analyses for nonconformities, including contamination issues. Design History Files were not established, and formal design reviews with proper documentation and independent participation were absent for various in vitro diagnostic (IVD) products. Furthermore, risk analysis was incomplete, with Risk Management Files not finalized for IVDs. Additional violations included undocumented process validation for IVDs and warehouse software, and inadequate complaint handling procedures. The firm also failed to ensure purchased products and services met specifications, lacking documented supplier verification, clear essential process activities for contractors, and timely complaint reporting from distributors. The company is required to address these systemic failures to comply with quality system regulations.