FDA 483 - HansBiomed USA, Inc. - November 08, 2022

An FDA inspection of HansBiomed USA, Inc., a medical device initial importer in Englewood Cliffs, NJ, revealed four significant observations. The firm failed to maintain adequate written Medical Device Reporting (MDR) procedures and did not register for the eMDR system. Additionally, deficiencies were noted in complaint handling, including a lack of trending analysis and non-English investigation records, alongside a failure to perform internal quality audits.