Willamette Shelling, Inc.
483 response sent October 23, 2009 · Newberg, Oregon
- Inspection
- Oct 17, 2009
- Investigators
- Jeffrey J. Leclair· Jinkee M. Vila-Binayug
- Observations
- 6
- Pages
- 6
- FEI number
- 3010692
In short: This is Willamette Shelling, Inc.'s written response to FDA, dated October 23, 2009, for its site in Newberg, Oregon (FEI 3010692). It sets out the corrective actions the firm committed to.
At a glance
6 of 6 observations on this response concern food cgmp / preventive controls.
Most cited: 21 CFR 110.10 (3×) · 110.35 (2×)
What the firm responded to
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
. ,:.' - .. 11…
- 02
Employee meeting has taken place and the employee's have been instructed about the following: That all…
- 03
, ~ ... Plastic curtains to be washed and sanitized. If not able to do then…
- 05
Employee meeting has taken place and was noted that all jewelry would not be allowed in…
2 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full responseThis inspection in context
Jeffrey J. Leclair
5 documents · 2009–2020
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 documentsOther sites cited under 110.10
See how FDA wrote the same problem up elsewhere.
Questions about this response
Who inspected Willamette Shelling, Inc.?
Jeffrey J. Leclair and Jinkee M. Vila-Binayug are named on this 483 response, for the inspection of Oct 17, 2009. Each investigator has a profile showing what they cite most.
When was Willamette Shelling, Inc. inspected by FDA?
The inspection ran Oct 17, 2009, and the 483 response is dated October 23, 2009.
How do I get the full 483 response for Willamette Shelling, Inc.?
Download the original PDF from FDA Intel for $199, with no subscription. You also get an invoice PDF with the order.