Medin Technologies, Inc. – FDA EIR, Feb 16, 2022

An FDA Level II Quality System Inspection of Medin Technologies, Inc., located in Totowa, NJ, was conducted from December 15, 2021, to February 16, 2022. The inspection, guided by the FDA’s Quality Systems Inspection Technique (QSIT) and regulations like 21 CFR Part 820 for medical device manufacturers, identified significant deficiencies in the company's quality management system for their Class I sterilization cases, trays, and racks.

The FDA issued a Form 483 listing seven observations. Key issues included inadequately established procedures for corrective and preventive actions, with examples of delayed CAPA initiation and incomplete investigations. Complaint handling processes were found deficient, lacking uniform documentation, timely processing, and essential information for investigations. The company also failed to conduct internal quality audits and management reviews at defined intervals, as stipulated by their own procedures. Furthermore, Medin Technologies did not adequately establish records of acceptable suppliers, failing to monitor them as required and maintaining inconsistent risk classifications. Finally, training procedures were not adequately established, with training records for some employees created only after the FDA's request, and instances of training not completed within specified timeframes.

In response to the observations, Medin Technologies, Inc. pledged to correct all identified deficiencies and committed to submitting a formal written response to the FDA within 15 business days.