FDA 483 - Medas, Inc. - July 25, 2022

Medas Inc., a repackager and relabeler, underwent an FDA inspection from July 20 to July 25, 2022. The inspection resulted in an FDA Form 483, citing several quality system deficiencies indicating non-compliance with regulatory requirements for medical devices.

Key observations included inadequate procedures for corrective and preventive actions. Specifically, the company failed to investigate an unmet 2021 customer satisfaction objective, without documenting root cause analysis, corrective action plans, or verification.

Additionally, procedures for controlling storage areas were insufficient. Medas Inc. lacked a designated "Quarantine / Rejected" area for nonconforming incoming products, contrary to its own written procedures. A discrepancy was also noted between company procedures, which stated no temperature requirements for products, and specific product instructions for use that mandated temperature precautions (e.g., below 40° C).

The inspection further identified that procedures for the routine calibration, inspection, and maintenance of equipment were not established, particularly for a thermometer used in the finished product warehouse. Finally, the firm's Medical Device Reporting (MDR) procedures were incomplete, omitting the current regulatory requirement for electronic submissions of adverse event reports to the FDA. Medas Inc. has acknowledged these observations and committed to implementing corrective actions for each.