Church & Dwight Co., Inc.
Form 483 issued May 23, 2019 · Lakewood, New Jersey
- Inspection
- May 15 – May 23, 2019
- Investigator
- Frederick Razzaghi
- Observations
- 4
- Pages
- 2
- FEI number
- 2224549
In short: On May 23, 2019, FDA issued a Form 483 with 4 observations to Church & Dwight Co., Inc. in Lakewood, New Jersey (FEI 2224549) after an inspection that ran May 15 – May 23, 2019. The investigator was Frederick Razzaghi. 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
Production system Equipment used in the manufacture, processing, packing or holding of drug products is not…
- 02
Laboratory system Laboratory records do not foclude complete records of testing and standardization…
- 03
Quality system Records demonstrating the Biological Safety Cabinet model (b) (4) meets a recognized standard suitable…
- 04
Production system The batch production and control records are deficient in that they do not include…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmChurch & Dwight Co., Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
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 production. The opening words of each observation are shown on this page.
Who inspected Church & Dwight Co., Inc.?
Frederick Razzaghi is named on this Form 483, for the inspection of May 15 – May 23, 2019. Each investigator has a profile showing what they cite most.
When was Church & Dwight Co., Inc. inspected by FDA?
The inspection ran May 15 – May 23, 2019, and the Form 483 is dated May 23, 2019.
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.