# FDA 483 - Church & Dwight Co., Inc. - October 25, 2024

Source: https://www.keypedia.com/records/483/church-dwight-co-inc/3876a388-5467-4098-ad20-e3f5475a7d3b

> FDA 483 for Church & Dwight Co., Inc. on October 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Church & Dwight Co., Inc.
- Inspection Date: 2024-10-25
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Church & Dwight Co., Inc. in Lakewood, NJ, received a Form 483 for significant deficiencies in their OTC drug manufacturing operations. Observations included inadequate component testing for harmful impurities, insufficient finished product and stability testing, unqualified equipment, and a lack of proper reserve sample examination procedures. These issues indicate a need for improved quality control and adherence to cGMP regulations.

## Related Documents

- [483 - 2019-05-23](https://www.keypedia.com/records/483/church-dwight-co-inc/02d26f95-d208-4cf5-ac4b-c56257e8ab97)

## Related Officers

- [Alisha B. Patel](https://www.keypedia.com/people/alisha-b-patel/3c106dac-0e0d-41f2-9f7a-69982d4e6579)
- [Drug Investigator](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [Yaharn Su](https://www.keypedia.com/people/yaharn-su/75b7f7fd-d853-436e-b538-386a8c6df3cb)
- [Yuharn Su](https://www.keypedia.com/people/yuharn-su/f0834535-2b6a-4c89-b812-a995434c53e6)

Company: https://www.keypedia.com/companies/church-dwight-co-inc/d49e7802-d435-46ac-a95b-029bb35bff98

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248