Dimensional Merchandising Inc.
Form 483 issued July 19, 2018 · Wharton, New Jersey
- Inspection
- Jul 11 – Jul 19, 2018
- Investigator
- Tonia F. Bernard
- Observations
- 3
- Pages
- 2
- FEI number
- 2242642
In short: On July 19, 2018, FDA issued a Form 483 with 3 observations to Dimensional Merchandising Inc. in Wharton, New Jersey (FEI 2242642) after an inspection that ran Jul 11 – Jul 19, 2018. The investigator was Tonia F. Bernard. Most observations concern facilities & equipment.
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Buildings used in the manufacturing of a drug product are not maintained in a…
This inspection in context
Tonia F. Bernard
13 documents · 2016–2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
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 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dimensional Merchandising Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Dimensional Merchandising Inc.?
Tonia F. Bernard is named on this Form 483, for the inspection of Jul 11 – Jul 19, 2018. Each investigator has a profile showing what they cite most.
When was Dimensional Merchandising Inc. inspected by FDA?
The inspection ran Jul 11 – Jul 19, 2018, and the Form 483 is dated July 19, 2018.
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.