# Beacon Bio Dx LLC – FDA 483, Jul 28, 2023

Source: https://www.keypedia.com/records/483/beacon-bio-dx-llc/d35d57e8-ee2c-46a1-811d-dc5c17a84619

> FDA 483 for Beacon Bio Dx LLC on July 28, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beacon Bio Dx LLC
- Inspection Date: 2023-07-28
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Cleveland Medical Devices Inc., a medical device manufacturer in Cleveland, OH, was cited for significant deficiencies across its quality system. Observations included inadequate documentation of corrective and preventive actions, incomplete risk analysis procedures, poorly established complaint handling processes, and insufficient purchasing controls and supplier assessment procedures. These issues indicate a systemic lack of robust quality management practices.

## Related Officers

- [Felicia E Hinojosa](https://www.keypedia.com/people/felicia-e-hinojosa/205e8143-c9aa-45a7-8c93-d8842dc51acb)
- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/beacon-bio-dx-llc/87793c4f-a78d-48bb-a97a-cbe0b1afdf9f

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22