Dimensional Merchandising Inc.
Form 483 issued April 18, 2023 · Wharton, New Jersey
- Inspection
- Apr 11 – Apr 18, 2023
- Investigator
- Karen A. Briggs
- Observations
- 4
- Pages
- 4
- FEI number
- 2242642
In short: On April 18, 2023, FDA issued a Form 483 with 4 observations to Dimensional Merchandising Inc. in Wharton, New Jersey (FEI 2242642) after an inspection that ran Apr 11 – Apr 18, 2023. The investigator was Karen A. Briggs. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Karen A. Briggs
19 documents · 2021–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
The firmDimensional Merchandising 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 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dimensional Merchandising Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Dimensional Merchandising Inc.?
Karen A. Briggs is named on this Form 483, for the inspection of Apr 11 – Apr 18, 2023. Each investigator has a profile showing what they cite most.
When was Dimensional Merchandising Inc. inspected by FDA?
The inspection ran Apr 11 – Apr 18, 2023, and the Form 483 is dated April 18, 2023.
How do I get the full Form 483 for Dimensional Merchandising 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.