Inter Bio-Lab, Inc. – FDA 483, Dec 5, 2019

Inter Bio-Lab, Inc., a medical device manufacturer in Orlando, FL, was cited for three observations related to inadequate complaint handling and Medical Device Reporting (MDR) procedures. The firm lacked established written procedures for managing complaints, failed to investigate device failure complaints, and did not maintain adequate written MDR procedures. These issues indicate significant deficiencies in their quality system for post-market surveillance.