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483
•Church & Dwight Co., Inc.•July 12, 2023

Church & Dwight Co., Inc. – FDA 483, Jul 12, 2023

Record Details

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.

Company
Church & Dwight Co., Inc.
Inspection date
July 12, 2023
Product type
drugs
Office
Cincinnati District Office
Person
  • Wen Ning Chan (Mathematical statistician)
View Company Profile

ID · 2982a3b4-cda1-4702-8687-8286b946b7ac

Other documents for Church & Dwight Co., Inc.
  • 483 - 2026-07-16July 16, 2026
  • EIR - 2023-07-12July 12, 2023
  • 483 - 2018-04-27April 27, 2018
  • 483 - 2012-12-17December 17, 2012

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