Estrella Family Creamery, LLC
Form 483 issued September 10, 2010 · Montesano, Washington
- Inspection
- Sep 1 – Sep 10, 2010
- Investigator
- Scott W. Fox
- Observations
- 10
- Pages
- 3
- FEI number
- 3004392984
In short: On September 10, 2010, FDA issued a Form 483 with 10 observations to Estrella Family Creamery, LLC in Montesano, Washington (FEI 3004392984) after an inspection that ran Sep 1 – Sep 10, 2010. The investigator was Scott W. Fox. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.10 (personnel).
At a glance
10 of 10 observations on this 483 concern food cgmp / preventive controls.
What FDA observed
Preview: the opening words of each observation- 01
Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for…
- 02
Failure to take necessary precautions to protect against contamination offood and food contact surfaces with…
- 03
Employees did not wash hands thoroughly in an adequate hand-washing facility after each absence from the…
- 04
Suilable outer gannents are not worn that protect against conlamination of food…
This inspection in context
Scott W. Fox
3 documents · 2010
Cites 110.10(b)(1) (personnel) more than any other section. Most of their documents are for sites in Washington.
The firmEstrella Family Creamery, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 110.80(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Estrella Family Creamery, LLC?
FDA listed 10 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 Estrella Family Creamery, LLC?
Scott W. Fox is named on this Form 483, for the inspection of Sep 1 – Sep 10, 2010. Each investigator has a profile showing what they cite most.
When was Estrella Family Creamery, LLC inspected by FDA?
The inspection ran Sep 1 – Sep 10, 2010, and the Form 483 is dated September 10, 2010.
How do I get the full Form 483 for Estrella Family Creamery, LLC?
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.