On April 9, 2012, the U.S. Food and Drug Administration (“FDA”) announced it has entered into a consent decree with a Washington State cheese producer. The company, Del Bueno, which processes and distributes cheeses, and its owner Jesus Rodriguez, agreed to the terms of a consent decree recently entered by U.S. District Judge, Lonny Suko, in the Eastern District of Washington. As part of the consent decree, Del Bueno cannot sell or otherwise distribute any food products unless and until it first proves that its goods are safe for human consumption. To this end, Del Bueno must develop a control program for its production process to ensure that the deadly pathogen Listeria monocytogenes is eliminated from its production facilities and products.
The consent decree comes after a long line of problems for the company. In particular, Del Bueno initiated voluntary recalls of its various cheese products throughout 2010, all prompted by concerns of a possible outbreak of illness due to the presence of Listeria monocytogenes. Making headlines throughout much of fall 2011 due to the deadly outbreak associated with consumption of cantaloupes, discussed here, Listeria monocytogenes is a foodborne pathogen that causes listeriosis. While listeriosis is typically not a life-threatening illness for all consumers, it can be fatal for very young children, elderly people and those with weakened immune systems, including those who are pregnant.
In addition to the recalls, on April 1, 2011, the FDA issued Del Bueno a Warning Letter. Found here, the Warning Letter came as a result of FDA’s inspection of the Company’s facilities, during which surfaces were swabbed and found to contain the presence of Listeria monocytogenes. After the issuance of the Warning Letter, the FDA ultimately took further action against the company, resulting in the recent consent decree.
Warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the Federal Food, Drug & Cosmetic Act (“FFDCA”) and/or FDA regulations. Judicial action is typically only pursued after less formal measures are proven unsuccessful. Thus, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance activities. For more information about establishing or maintaining compliance with the regulations or laws FDA enforces, please contact us at email@example.com.