On April 28, 2014, the U.S. Food and Drug Administration (“FDA”) prevailed in federal court in its action against Nancy Taber Richards and the company she co-founded, Trumansburg, N.Y.-based Finger Lakes Farmstead Cheese Company, LLC. In particular, the Western District of New York’s U.S. District Court entered a consent decree of permanent injunction against the New York dairy manufacturer due to the detection of listeria contamination. News pertaining to the consent decree and prior warning letter can be found here.
According to the consent decree, the company Finger Lakes has been prohibited from the further manufacturing, preparation, processing, packaging, storage and distribution of food until evidence of a control program designed to eliminate the Listeria monocytogenes (“L. monocytogenes“) from both its production facilities and products. L. monocytogenes is a pathogen that can occur in various food products, causing sickness and fatalities.
The consent decree is the result of finger lakes failure to address deficiencies in its food processing operations, noted as recently as october 23, 2012 in a warning letter issued by the FDA. The warning letter issued by the FDA noted the company’s violation of the current good manufacturing practice regulation for food found in Title 21, Code of Federal Regulations, Part 110 [21 Cfr Part 110]. Additionally, the existence of the L. monocytogenes pathogen in ready-to-eat products produced by the company constitutes a violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §342(a)(4)] with respect to the manufacture and sale of food products that contain a poisonous or deleterious substance that may be harmful to the public’s health.
Finger Lakes had been warned by the FDA on several occasions regarding the unsanitary conditions within the company’s facilities that led to the Listeria contamination. Laboratory testing in both 2012 and 2013 uncovered the existence of the L. monocytogenes pathogen and led the FDA to take action pursuant to its regulatory authority under federal law. Warning letters are typically FDA’s first course of action against parties deemed noncompliant with federal regulations and are a type of informal agency action that is used to signal the possibility of future enforcement should the alleged deficiencies not be remedied. Thus, it is important to take warning letters seriously and complete any necessary corrective actions in order to thwart the possibility of further agency action.
If you have any questions about the FDA’s food product safety regulations, warning letters, or how you can maintain compliance with FDA regulations, please contact us at firstname.lastname@example.org.