# Church & Dwight Co., Inc. – FDA 483, Jul 16, 2026

Source: https://www.keypedia.com/records/483/church-dwight-co-inc/ca41c293-c6c6-4752-a67f-1e13dd5cf378

> FDA 483 for Church & Dwight Co., Inc. on July 16, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Church & Dwight Co., Inc.
- Inspection Date: 2026-07-16
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Church & Dwight Co., Inc. in Old Fort, OH, an API and drug manufacturer, revealed two significant observations. The firm's laboratory controls for volumetric solutions lacked scientific justification for expiration periods and adequate re-standardization. Additionally, the computerized control system for drug production had a shared "Guest" login and insufficient traceability for changes to critical process parameters, indicating potential data integrity and quality control deficiencies.

## Related Documents

- [EIR - 2023-07-12](https://www.keypedia.com/records/eir/church-dwight-co-inc/a98a3de4-b37f-492c-b5da-7b9b35bb0dbf) — date: July 12, 2023
- [483 - 2023-07-12](https://www.keypedia.com/records/483/church-dwight-co-inc/2982a3b4-cda1-4702-8687-8286b946b7ac) — date: July 12, 2023
- [483 - 2018-04-27](https://www.keypedia.com/records/483/church-dwight-co-inc/cb43739c-9add-49f0-91c8-689e41b10879) — date: April 27, 2018
- [483 - 2012-12-17](https://www.keypedia.com/records/483/church-dwight-co-inc/11e8a61a-383e-4a62-87e5-ec331214368f) — date: December 17, 2012

## Related Officers

- [Supreet K. Sran](https://www.keypedia.com/people/supreet-k-sran/1dab51f8-b483-4ccb-8b44-89fdc3b8100b)
- [investigator](https://www.keypedia.com/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)
- [Kara J. Wright](https://www.keypedia.com/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.keypedia.com/companies/church-dwight-co-inc/d87194ae-f106-4ad7-9bc2-49ca798f781d

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