# FDA 483 - DimcoGray Inc. - February 09, 2023

Source: https://www.keypedia.com/records/483/dimcogray-inc/bf066328-eb24-475c-9bb7-d3bf8a5018d9

> FDA 483 for DimcoGray Inc. on February 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DimcoGray Inc.
- Inspection Date: 2023-02-09
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: DimcoGray Inc., a contract manufacturer in Centerville, OH, was inspected by the FDA from February 6-9, 2023. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures, specifically concerning the timely completion of risk analyses and priority ratings for CAPAs. This indicates a moderate level of non-compliance with quality system requirements.

## Related Documents

- [483 - 2018-09-17](https://www.keypedia.com/records/483/dimcogray-inc/07792053-7b55-402c-bd84-3acd27e8e293)

## Related Officers

- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

Company: https://www.keypedia.com/companies/dimcogray-inc/9ea4c42d-f2c7-429f-aad2-3259ae7e1d00

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