# FDA 483 - Church & Dwight Co., Inc. - April 27, 2018

Source: https://www.keypedia.com/records/483/church-dwight-co-inc/cb43739c-9add-49f0-91c8-689e41b10879

> FDA 483 for Church & Dwight Co., Inc. on April 27, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Church & Dwight Co., Inc.
- Inspection Date: 2018-04-27
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Church & Dwight Company Inc, an API manufacturer in Old Fort, OH, received two observations during an FDA inspection. The firm's Quality Control Unit failed to timely close Quality Investigation Reports and monitor their effectiveness. Additionally, the inspection revealed inadequate controls over computer systems, including issues with data integrity, audit trails, user access, and data backup procedures.

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## Related Officers

- [Program Analyst](https://www.keypedia.com/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)

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