Primrose Candy Company
Form 483 issued September 26, 2017 · Chicago, Illinois
- Inspection
- Jul 10 – Sep 26, 2017
- Investigator
- Nicholas P. Diorio
- Observations
- 7
- Pages
- 8
- FEI number
- 1412287
In short: On September 26, 2017, FDA issued a Form 483 with 7 observations to Primrose Candy Company in Chicago, Illinois (FEI 1412287) after an inspection that ran Jul 10 – Sep 26, 2017. The investigator was Nicholas P. Diorio. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Manufacturer Reports of analysis from component suppliers are accepted in lieu of testing each component for…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Nicholas P. Diorio
8 documents · 2013–2025
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Illinois.
The firmPrimrose Candy Company history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Primrose Candy Company?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Primrose Candy Company?
Nicholas P. Diorio is named on this Form 483, for the inspection of Jul 10 – Sep 26, 2017. Each investigator has a profile showing what they cite most.
When was Primrose Candy Company inspected by FDA?
The inspection ran Jul 10 – Sep 26, 2017, and the Form 483 is dated September 26, 2017.
How do I get the full Form 483 for Primrose Candy Company?
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.