FDA WARNING_LETTER - Pacific Cheese Company, Inc. - March 04, 2011

The FDA inspected Pacific Cheese Company, Inc.'s Hayward, CA facility from February 18 to March 4, 2011, following a Reportable Food Registry report. Samples of cubed and shredded cheddar cheese collected from a third-party warehouse on February 28, 2011, tested positive for *Listeria monocytogenes*. This renders the cheese products adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, as they contain a poisonous or deleterious substance.

The firm conducted a voluntary recall and destroyed the affected lot in February and May 2011, respectively. However, the FDA deemed the company's March 18, 2011, response to the FDA Form 483 inadequate. The response mentioned additional environmental sampling after intensified sanitation but did not provide the results. Furthermore, the corrective actions lacked measures to prevent future contamination of food or food contact surfaces with *L. monocytogenes*, such as documented steps for responding to positive environmental samples.

The FDA requires a written response within 15 working days detailing the current status of corrective actions, including specific steps taken to correct violations and prevent reoccurrence, along with supporting documentation. Failure to implement lasting corrective actions may result in regulatory action, including product seizure and/or injunction against firm operations.