# FDA 483 - Remel Cleveland, a Division of Remel Inc. - November 20, 2019

Source: https://www.globalkeysolutions.net/records/483/remel-cleveland-a-division-of-remel-inc/09f49796-3b36-4809-97a3-9bdb2ca59bd5

> FDA 483 for Remel Cleveland, a Division of Remel Inc. on November 20, 2019. 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: 2019-11-20
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Rem I, Inc. in Oakwood Village, OH, a medical device specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including trending, investigation thresholds, and verification of effectiveness. Additionally, complaint handling procedures were found to be inadequate, with issues such as missing complaints, unassigned cause codes, and insufficient investigation justifications.

## Related Documents

- [483 - 2025-02-03](https://www.globalkeysolutions.net/records/483/remel-cleveland-a-division-of-remel-inc/e1c22f8a-e5ac-4b68-aa4d-6391ce67aa1e)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

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