Church & Dwight Co., Inc.
Form 483 issued April 27, 2018 · Old Fort, Ohio
- Inspection
- Apr 24 – Apr 27, 2018
- Investigator
- Jazmine N. Still
- Observations
- 2
- Pages
- 4
- FEI number
- 1525647
In short: On April 27, 2018, FDA issued a Form 483 with 2 observations to Church & Dwight Co., Inc. in Old Fort, Ohio (FEI 1525647) after an inspection that ran Apr 24 – Apr 27, 2018. The investigator was Jazmine N. Still. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Church & Dwight Co., Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Church & Dwight Co., Inc.?
Jazmine N. Still is named on this Form 483, for the inspection of Apr 24 – Apr 27, 2018. Each investigator has a profile showing what they cite most.
When was Church & Dwight Co., Inc. inspected by FDA?
The inspection ran Apr 24 – Apr 27, 2018, and the Form 483 is dated April 27, 2018.
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.