Federal Court Filings Reveal Details of Estrella Family Creamery Closure

I've been able to hunt down the court filings related to the recent closure of Estrella Family Creamery (see download available below). The documents reveal the FDA's reasoning behind the recent enforcement actions in detail.

Most significant is the affidavit of FDA official Lisa Ellrand (Exhibit A to the document). Let's reconstruct the timeline.

Earlier this year, the FDA performed a number of tests at Estrella Family Creamery. Several of these tests were positive for listeria. As we already know, recalls were initiated on February 11th, 2010 (Red Darla) , February 17th, 2010 (Brewleggio, Wynoochee River Blue and Domino), and on March 5, 2010 (Old Apple Tree Tomme).

According to the FDA inspector's affidavit, the FDA again performed tests at the creamery several times in August of 2010. Samples collected in August also tested positive for listeria.

According to the FDA inspector's affidavit, the tests revealed that the same strain of l. mono was present in the tests performed in early 2010 and the tests performed later in the year, in August. According to the FDA, this indicates that the creamery's eradication practices had not been sufficient, over time, to remove the offending pathogen.

The affidavit also states that Estrella's own lab reports revealed positive tests in May, June, July and August of 2010. There seems to be some contention that the Estrellas kept these results from FDA inspectors.

In early September of 2010, the FDA asked the Estrellas to initiate a recall. According to the FDA, they declined. (I believe that at that time, the Estrellas' reasoning was that no products were available to the public.) The FDA then issued its caution letter of September 4th, 2010.

The affidavit also details a pattern of unsanitary practices at the creamery.

In the end, because there was no evidence that the pathogen was fully eradicated from the creamery, the FDA shut the creamery down.

Download the recent court filing below:

Estrella filing

Update: See the article, with comments by Kelli Estrella, in the Seattle Times here.