Church & Dwight Co., Inc.
Form 483 issued December 21, 2012 · Old Fort, Ohio
- Inspection
- Dec 17 – Dec 21, 2012
- Observations
- 4
- Pages
- 2
- FEI number
- 1525647
In short: On December 21, 2012, FDA issued a Form 483 with 4 observations to Church & Dwight Co., Inc. in Old Fort, Ohio (FEI 1525647) after an inspection that ran Dec 17 – Dec 21, 2012. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm has not established an appropriate procedure for…
- 02
Your firm does not properly maintain all buildings and equipment in a…
- 03
Your firm has not established appropriate specifications…
- 04
Your firm does not…
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, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was Church & Dwight Co., Inc. inspected by FDA?
The inspection ran Dec 17 – Dec 21, 2012, and the Form 483 is dated December 21, 2012.
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.