Primrose Candy Company
Form 483 issued November 19, 2021 · Chicago, Illinois
- Inspection
- Nov 15 – Nov 19, 2021
- Investigator
- Torrey M. Ward
- Observations
- 12
- Pages
- 8
- FEI number
- 1412287
In short: On November 19, 2021, FDA issued a Form 483 with 12 observations to Primrose Candy Company in Chicago, Illinois (FEI 1412287) after an inspection that ran Nov 15 – Nov 19, 2021. The investigator was Torrey M. Ward. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Laboratory controls and production account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 03
There is no written testing program designed to assess the stability characteristics…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Torrey M. Ward
13 documents · 2021–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Iowa.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Primrose Candy Company?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Primrose Candy Company?
Torrey M. Ward is named on this Form 483, for the inspection of Nov 15 – Nov 19, 2021. Each investigator has a profile showing what they cite most.
When was Primrose Candy Company inspected by FDA?
The inspection ran Nov 15 – Nov 19, 2021, and the Form 483 is dated November 19, 2021.
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.