Infectious Diseases 2019

Infectious Diseases 2019

FDA: A letter from the FDA to Gravel Ridge Farm

7 March, 2019

The FDA sent the owners of Gravel Ridge Farm facility a warning letter on February 12, 2019.
Gravel Ridge Farms recalled more than 600,000 shell eggs in response to this outbreak.
The United States Food and Drug Administration (FDA) inspected your shell egg farm, located at 1550 County Road 1490, Cullman, Alabama, from September 5 – 7, 12, 20, and 25, 2018.  The inspection was initiated as part of a Salmonella Enteritidis (SE) multi-state outbreak investigation by FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network. According to CORE and the Centers for Disease Control and Prevention (CDC), 45 people in 12 states were infected with the outbreak strain of SE, which is the same strain found in one environmental swab from your egg laying house No. 2, and one environmental swab from your egg laying house No. 4.  Further, FDA’s Whole Genome Sequence (WGS) analysis of these isolates of SE revealed they are genetically identical to 45 clinical isolates from ill patients sequenced to date.  Moreover, as you are aware, CDC and FDA have determined, based on the epidemiological, traceback, and laboratory evidence, that shell eggs produced at your Cullman, Alabama location are the likely source of this multi-state SE outbreak. In addition, during our inspection we found your firm was in violation of FDA’s egg safety rule.
In addition, your shell eggs are adulterated within the meaning of Section 402(a)(4) of the FD&C Act, 21 USC 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.  During the inspection, two environmental samples were collected and analyzed for SE. SE was detected in Sample 1050366, collected from House No. 4; and Sample 1081755, collected from House No. 2, at your farm. FDA acknowledges your voluntary action, on or about September 14, 2018, which included the termination of the entire flock of layer hens held in Houses No. 4 and No. 2 and subsequent disposal/destruction of the eggs from the flocks.
You submitted a written response which was received on October 8, 2018. We are aware you have currently recalled all eggs, depopulated all flocks, and have ceased egg production. 
Your significant violations were as follows: 
1.   You did not have and implement a written Salmonella Enteritidis (SE) prevention plan. 
2.   An environmental test for SE was not conducted for each poultry house as required by 21 CFR 118.7(a).  

Related Links
Link The Full Letter