Willamette Shelling, Inc.
Form 483 issued November 20, 2009 · Newberg, Oregon
- Inspection
- Nov 17 – Nov 20, 2009
- Investigators
- Graham N. Giesen· Jeffrey J. Leclair· Vila Binayug
- Observations
- 7
- Pages
- 4
- FEI number
- 3010692
In short: On November 20, 2009, FDA issued a Form 483 with 7 observations to Willamette Shelling, Inc. in Newberg, Oregon (FEI 3010692) after an inspection that ran Nov 17 – Nov 20, 2009. The investigators were Graham N. Giesen, Jeffrey J. Leclair and Vila Binayug. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.10 (personnel).
At a glance
7 of 7 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.10 (3×) · 110.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Effective measures are not being taken to exclude pests…
- 02
Employees did not wash hands thoroughly in an adequate hand-washing facility before starting work, after each…
- 03
All reasonable precautions are not taken to ensure that production procedures do not contribute…
- 04
Failure to manufacture, package, and store foods under conditions and controls necessary to minimize the potential…
This inspection in context
Graham N. Giesen
1 document · 2009
Cites 110.10 (personnel) more than any other section. Most of their documents are for sites in Oregon.
The firmWillamette Shelling, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 110.10
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Willamette Shelling, Inc.?
FDA listed 7 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.10 (personnel). The opening words of each observation are shown on this page.
Who inspected Willamette Shelling, Inc.?
Graham N. Giesen, Jeffrey J. Leclair and Vila Binayug are named on this Form 483, for the inspection of Nov 17 – Nov 20, 2009. Each investigator has a profile showing what they cite most.
When was Willamette Shelling, Inc. inspected by FDA?
The inspection ran Nov 17 – Nov 20, 2009, and the Form 483 is dated November 20, 2009.
How do I get the full Form 483 for Willamette Shelling, Inc.?
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.