# FDA 483 - Codonics Inc - March 21, 2025

Source: https://www.keypedia.com/records/483/codonics-inc/1b9e8955-d038-4c48-bbdb-18602e65a5d2

> FDA 483 for Codonics Inc on March 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Codonics Inc
- Inspection Date: 2025-03-21
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Codonics Inc, a medical device manufacturer in Cleveland, OH, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for complaint handling, risk analysis, document control, and corrective and preventive actions. These issues indicate a systemic breakdown in ensuring product quality and safety.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/codonics-inc/7beb427a-10a6-44b2-a627-5d5ef8c45f77

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