# FDA 483 - Church & Dwight Co., Inc. - July 12, 2023

Source: https://www.keypedia.com/records/483/church-dwight-co-inc/2982a3b4-cda1-4702-8687-8286b946b7ac

> FDA 483 for Church & Dwight Co., Inc. on July 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Church & Dwight Co., Inc.
- Inspection Date: 2023-07-12
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Church & Dwight Co., Inc. in Old Fort, OH, a manufacturer of Sodium Bicarbonate, USP, revealed significant deficiencies. The firm failed to validate its process water system and lacked written procedures for its maintenance. Additionally, issues with data integrity were noted, as a QMS supervisor had administrative access with delete capabilities to critical test data.

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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