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

Source: https://www.keypedia.com/records/483/pro-med-instruments-inc/dbb14e1c-10f8-472a-8965-3b6fcc883034

> FDA 483 for Pro Med Instruments, Inc. on February 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pro Med Instruments, Inc.
- Inspection Date: 2023-02-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/pro-med-instruments-inc/daab7c5f-c614-48fd-a241-3ff52aaade26

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6