Form 483 · FEI 3003051915
Form 483 issued August 29, 2020 · Ashland, Oregon
- Inspection
- Jul 15, 2014 – Aug 29, 2020
- Investigators
- Christopher R. Czajka· Crystal A. Harlan· Ian J. Thomson
- Observations
- 8
- Pages
- 4
- FEI number
- 3003051915
In short: On August 29, 2020, FDA issued a Form 483 with 8 observations to an FDA-inspected site in Ashland, Oregon (FEI 3003051915) after an inspection that ran Jul 15, 2014 – Aug 29, 2020. The investigators were Christopher R. Czajka, Crystal A. Harlan, Ian J. Thomson, Jeffrey J. Leclair and Leon R. Marquart. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 117.35 (sanitary operations).
At a glance
8 of 8 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 117.35 (2×) · 117.40 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to manufacture foods under conditions and controls necessary to minimize the potential for…
- 02
Failure to maintain equipment in an acceptable condition through…
- 03
Employees did not wash bands thoroughly in an adequate hand-washing facility at any time their hands…
- 04
Food contact surfaces are not designed to withstand the…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 117.35
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 8 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 117.35 (sanitary operations). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Christopher R. Czajka, Crystal A. Harlan, Ian J. Thomson, Jeffrey J. Leclair and Leon R. Marquart are named on this Form 483, for the inspection of Jul 15, 2014 – Aug 29, 2020. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 15, 2014 – Aug 29, 2020, and the Form 483 is dated August 29, 2020.
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.