Pacific Cheese Company, Inc. 8/1/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94501-7070 Telephone: (510) 337-6700

Via UPS Overnight Delivery
Signature Required

WARNING LETTER

August 1, 2011

Reference# 2917583

Stephen B. Gaddis, President
Pacific Cheese Company, Inc.
21090 Cabot Boulevard
Hayward, CA 94545

Dear Mr. Gaddis:

The U.S. Food and Drug Administration (FDA) inspected your cheese processing facility located at 21090 Cabot Boulevard, Hayward, CA, from February 18 -March 4, 2011, in follow-up to a Reportable Food Registry report submitted to FDA by your firm. On February 28,2011, we collected samples 561346,561347,561348,561349,561350, at your third party warehouse, consisting of cubed and shredded cheddar cheese; laboratory analysis of these samples found the pathogen Listeria monocytogenes (L. monocytogenes). As evidenced by these sample results, your cheese products are adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 342(a)(1)], in that your cheeses contain a poisonous or deleterious substance which may render them injurious to health. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.

L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility. L. monocytogenes can contaminate foods, resulting in a mild illness (listerial gastroenteritis) or a severe, sometimes life threatening, illness called invasive listeriosis. Immune-compromised individuals and unborn fetuses are particularly susceptible to Listeriosis. L. monocytogenes can be isolated from soil, silage and other environmental sources and can also be found in man-made environments such as food processing establishments. Any moist area, such as your cheese production area, can harbor L. monocytogenes. This organism can grow at refrigeration temperatures.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and applicable regulations. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.

We acknowledge that you conducted a voluntary recall of the distributed products of the affected lot in February 2011 and the product was destroyed in May 2011. Also, we have reviewed your March 18, 2011 response to the FDA Form 483-Inspectional Observations issued to you at the close of the inspection and have determined that your response is inadequate. Specifically, you refer to having conducted additional environmental sampling after intensified sanitation of production equipment; however, you did not share the results of such sampling with Investigators at the conclusion of the inspection or in your response letter. Furthermore, your corrective action does not include measures that will prevent future contamination of food or food contact surfaces with L. monocytogenes from occurring again (e.g., documentation describing the steps that would be taken by your firm in response to environmental samples found positive for L. monocytogencs).

We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of implementing your corrective actions since your March 18, 2011 correspondence, including any further specific steps that you have taken to correct the noted violations and prevent them from reoccurrence. Include any documentation necessary to show that correction has been achieved. Please send your reply to the Food and Drug Administration, Attention: Darlene Almogela, Director, Compliance Branch, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Ms. Almogela at 510-337-6769.

Sincerely,

/s/

Barbara J. Cassens
District Director

cc: Lance C. Solus, Executive Vice President
     Pacific Cheese Company, Incorporated
     21090 Cabot Boulevard
     Hayward, CA 94545