FDA 483 - Medlink Imaging, LLC - July 26, 2021

During an FDA inspection from July 19-26, 2021, Medlink Imaging, LLC, an importer and distributor of Digital Radiography Equipment located in Pine Brook, NJ, received a Form FDA 483 with five observations. Jinho Lee (aka Peter Lee), Operating Manager and CEO, was the recipient of the report.

**Observation 1:** Quality system procedures and instructions were not established. Draft procedures and forms for a medical device quality system were not reviewed, approved, or implemented. The ISO 9001-based Quality Manual (QA-010, 08/20/2020) was not approved by upper management, and its stated scope ("Assembly and Test of Digital Panels") did not match the firm's current operations. Employees were unaware of the Quality Policy. This observation was "Promised to correct."

**Observation 2:** No management representative had been appointed to ensure quality system requirements were met and to report on system performance. This observation was "Corrected and verified."

**Observation 3:** Quality audits had not been performed since 2019, when the firm's scope of operations assumed its current extent. This observation was "Promised to correct."

**Observation 4:** Management with executive responsibility had not reviewed the suitability and effectiveness of the quality system, with no management reviews performed since 2019. This observation was "Promised to