Primrose Candy Company
Form 483 issued December 1, 2010 · Chicago, Illinois
- Inspection
- Nov 1 – Dec 1, 2010
- Investigator
- Christina A. Miller
- Observations
- 22
- Pages
- 11
- FEI number
- 1412287
In short: On December 1, 2010, FDA issued a Form 483 with 22 observations to Primrose Candy Company in Chicago, Illinois (FEI 1412287) after an inspection that ran Nov 1 – Dec 1, 2010. The investigator was Christina A. Miller. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
The quality control unit lacks the responsibility and authority to approve and…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Christina A. Miller
10 documents · 2010–2017
Cites 211.42 (design and construction features) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Primrose Candy Company?
FDA listed 22 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Primrose Candy Company?
Christina A. Miller is named on this Form 483, for the inspection of Nov 1 – Dec 1, 2010. Each investigator has a profile showing what they cite most.
When was Primrose Candy Company inspected by FDA?
The inspection ran Nov 1 – Dec 1, 2010, and the Form 483 is dated December 1, 2010.
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.