Primrose Candy Company
Form 483 issued February 25, 2021 · Chicago, Illinois
- Inspection
- Feb 18 – Feb 25, 2021
- Investigators
- Ana E. Morales· Logan M. Ebeling
- Observations
- 2
- Pages
- 3
- FEI number
- 1412287
In short: On February 25, 2021, FDA issued a Form 483 with 2 observations to Primrose Candy Company in Chicago, Illinois (FEI 1412287) after an inspection that ran Feb 18 – Feb 25, 2021. The investigators were Ana E. Morales and Logan M. Ebeling. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.27 (what requirements apply to the equipment and utensils that you use?).
At a glance
2 of 2 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.27(d) (1×) · 111.103 (1×)
What FDA observed
Preview: the opening words of each observation- 01
You did not maintain equipment and utensils used to manufacture, package, label, or hold…
- 02
You did not follow written procedures…
This inspection in context
Ana E. Morales
2 documents · 2021–2022
Cites 106.10(b)(1) (controls to prevent adulteration by workers) 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 111.27(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Primrose Candy Company?
FDA listed 2 observations on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.27 (what requirements apply to the equipment and utensils that you use?). The opening words of each observation are shown on this page.
Who inspected Primrose Candy Company?
Ana E. Morales and Logan M. Ebeling are named on this Form 483, for the inspection of Feb 18 – Feb 25, 2021. Each investigator has a profile showing what they cite most.
When was Primrose Candy Company inspected by FDA?
The inspection ran Feb 18 – Feb 25, 2021, and the Form 483 is dated February 25, 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.