Church & Dwight Co., Inc.
Form 483 issued October 25, 2024 · Lakewood, New Jersey
- Observations
- 4
- Pages
- 4
- FEI number
- 2224549
In short: On October 25, 2024, FDA issued a Form 483 with 4 observations to Church & Dwight Co., Inc. in Lakewood, New Jersey (FEI 2224549). Most observations concern laboratory controls and materials.
At a glance
Laboratory controls and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Questions about this 483
What did FDA find at Church & Dwight Co., Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, materials and facilities & equipment. The opening words of each observation are shown on this page.
When was Church & Dwight Co., Inc. inspected by FDA?
This Form 483 is dated October 25, 2024.
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.