Church & Dwight Co., Inc.
Form 483 issued July 12, 2023 · Old Fort, Ohio
- Inspection
- Jun 21 – Jul 12, 2023
- Investigator
- Wen Ning Chan
- Observations
- 3
- Pages
- 4
- FEI number
- 1525647
In short: On July 12, 2023, FDA issued a Form 483 with 3 observations to Church & Dwight Co., Inc. in Old Fort, Ohio (FEI 1525647) after an inspection that ran Jun 21 – Jul 12, 2023. The investigator was Wen Ning Chan. Most observations concern facilities & equipment.
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
This inspection in context
Wen Ning Chan
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmChurch & Dwight Co., Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Church & Dwight Co., Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Church & Dwight Co., Inc.?
Wen Ning Chan is named on this Form 483, for the inspection of Jun 21 – Jul 12, 2023. Each investigator has a profile showing what they cite most.
When was Church & Dwight Co., Inc. inspected by FDA?
The inspection ran Jun 21 – Jul 12, 2023, and the Form 483 is dated July 12, 2023.
How do I get the full Form 483 for Church & Dwight Co., Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.