Primrose Candy Company
Form 483 issued May 23, 2012 · Chicago, Illinois
- Inspection
- Apr 12 – May 23, 2012
- Observations
- 17
- Pages
- 8
- FEI number
- 1412287
In short: On May 23, 2012, FDA issued a Form 483 with 17 observations to Primrose Candy Company in Chicago, Illinois (FEI 1412287) after an inspection that ran Apr 12 – May 23, 2012. Most observations concern dietary supplement CGMP and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Dietary supplement CGMP and laboratory controls account for 11 of 17 observations.
Most cited: 21 CFR 211.160 (2×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans, and…
- 02
Written records are not made of…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Master production and control records lack complete…
This inspection in context
Questions about this 483
What did FDA find at Primrose Candy Company?
FDA listed 17 observations on this Form 483, mostly about dietary supplement CGMP, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Primrose Candy Company inspected by FDA?
The inspection ran Apr 12 – May 23, 2012, and the Form 483 is dated May 23, 2012.
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.