Form 483 · FEI 1000150986
Form 483 issued November 4, 2016 · Sandpoint, Idaho
- Inspection
- Nov 1 – Nov 4, 2016
- Observations
- 6
- Pages
- 3
- FEI number
- 1000150986
In short: On November 4, 2016, FDA issued a Form 483 with 6 observations to an FDA-inspected site in Sandpoint, Idaho (FEI 1000150986) after an inspection that ran Nov 1 – Nov 4, 2016. The most-cited regulation is 21 CFR 108.25 (acidified foods).
What FDA observed
Preview: the opening words of each observation- 0121 CFR 114.83
A scheduled process was not established by a qualified person who has expert knowledge acquired through…
- 02
Failure to register with the FDA information including the name, principal place of business and the…
- 03
Failure to provide the FDA, before packing any new product, information on the scheduled processes for…
- 04
Failure to have personnel involved in acidification, pH control and critical factors under the operating supervision…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 6 observations on this Form 483. The most-cited regulation is 21 CFR 108.25 (acidified foods). The opening words of each observation are shown on this page.
When was an FDA-inspected site inspected by FDA?
The inspection ran Nov 1 – Nov 4, 2016, and the Form 483 is dated November 4, 2016.
How do I get the full Form 483 for an FDA-inspected site?
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.