FDA 483 - Pro Med Instruments, Inc. - February 15, 2023

An FDA inspection of Pro Med Instruments, Inc. in Cape Coral, FL, an importer of medical devices, revealed four observations related to its quality system. The firm was cited for inadequate procedures for complaint handling and decontamination, as well as deficiencies in service report documentation and medical device importer reporting. These issues indicate a need for improved procedural adherence and record-keeping practices.