# FDA 483 - Kent Elastomer Products Inc - October 16, 2025

Source: https://www.keypedia.com/records/483/kent-elastomer-products-inc/8bc94c5f-79a8-4d39-8d4d-4515ca6791ff

> FDA 483 for Kent Elastomer Products Inc on October 16, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kent Elastomer Products Inc
- Inspection Date: 2025-10-16
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Kent Elastomer Products Inc, a contract medical device manufacturer in Kent, OH, received a Form FDA-483 with three observations. The inspection revealed inadequately established procedures for corrective and preventive actions (CAPA), supplier selection and assessment, and process validation. These findings highlight significant deficiencies in the firm's quality system documentation and implementation.

## Related Documents

- [483 - 2025-10-16](https://www.keypedia.com/records/483/kent-elastomer-products-inc/64667fc1-bf01-404a-a116-95bb6e0c9a45)

## Related Officers

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

Company: https://www.keypedia.com/companies/kent-elastomer-products-inc/694df4f0-caba-4773-8dc2-06fae1be2780

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