# FDA 483 - Remel Cleveland, a Division of Remel Inc. - February 03, 2025

Source: https://www.globalkeysolutions.net/records/483/remel-cleveland-a-division-of-remel-inc/e1c22f8a-e5ac-4b68-aa4d-6391ce67aa1e

> FDA 483 for Remel Cleveland, a Division of Remel Inc. on February 03, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Remel Cleveland, a Division of Remel Inc.
- Inspection Date: 2025-02-03
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Remel Inc. in Oakwood Village, OH, a medical device software manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system, particularly concerning the incomplete analysis and inadequate description of cause codes for complaint data. Additionally, the firm's product risk management was found to be inadequate, with outdated risk analysis documents and discrepancies in assigning potential severity levels for identified harms related to their medical device software.

## Related Documents

- [483 - 2019-11-20](https://www.globalkeysolutions.net/records/483/remel-cleveland-a-division-of-remel-inc/09f49796-3b36-4809-97a3-9bdb2ca59bd5)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/remel-cleveland-a-division-of-remel-inc/021debca-74ec-4d32-b2e1-1766d4b852d2

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