# FDA 483 - Criterion Tool & Die Inc - February 17, 2023

Source: https://www.globalkeysolutions.net/records/483/criterion-tool-die-inc/5f91c2d3-38e7-4bb2-99c3-aa3279b71114

> FDA 483 for Criterion Tool & Die Inc on February 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Criterion Tool & Die Inc
- Inspection Date: 2023-02-17
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Criterion Tool & Die Inc, a contract medical device manufacturer in Brookpark, OH, received a Form FDA 483 following an inspection from February 8-17, 2023. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, complaint handling, nonconforming product control, supplier approval, process validation, equipment maintenance, and employee training. These issues indicate a systemic lack of established and implemented quality management processes.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/criterion-tool-die-inc/9c38e1f7-bfb6-46f1-bf65-12523d1f4252

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