Inspections, Compliance, Enforcement, and Criminal Investigations
Del Bueno 4/1/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
April 1, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-10
Jesus Rodriguez Banuelos, Owner
695 ½ Wallace Way
Grandview, Washington 98930
Dear Mr. Rodriguez:
The U.S. Food and Drug Administration (FDA) inspected your cheese processing establishment, located at 695 ½ Wallace Way, Grandview, Washington, on October 18-20, 2010. On October 19, 2010, FDA collected environmental swabs (sample 593562) from various locations in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogemes), a human pathogen, in your facility. Our finding of L. monocytogenes in your processing facility causes your cheese products to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)], in that your cheeses have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
On November 1, 2010, FDA also collected two finished product samples 593563 and 593564, of your Queso Fresco Cheese at retail stores. These samples were both labeled in part: “DEL BUENO***Queso Fresco Fresh Cheese CASERO NET Wt. ***Keep Refrigerated Ingredients: Pasteurized Milk, Salt, Rennet, and Starter Culture Del Bueno 695 ½ Wallace Way, Grandview, WA 98930***.” Sample 593563 consisted of seven/16 oz. cheese wheels in vacuum-packed plastic packages and had a code date of “JAN 12 2011.” Sample 593564 consisted of four/3 lb. cheese wheels in vacuum-packed plastic packages and had a code date of “DEC 22 2010.” Both of these samples were contaminated with the pathogen L. monocytogenes rendering them adulterated within the meaning of section 402(a)(1) [21 U.S.C. § 342(a)(1)] of the Act, in that your cheese products contain a poisonous or deleterious substance which may render them injurious to health.
You may find the Act through links in FDA’s home page at www.fda.gov.
A report of analytical results for Samples 593563 and 593564 was mailed to you by our Pacific Regional Laboratory-Northwest on November 10, 2010. We acknowledge that on November 17, 2010, your firm conducted a voluntary recall of cheeses based on the results of environmental samples and finished product samples collected by FDA, and the result of the finished product samples collected by the Washington State Department of Agriculture (WSDA) which revealed the presence of L. monocytogenes.
Analysis using Pulsed Field Gel Electrophoresis ("PFGE") showed that L. monocytogenes isolates obtained from the FDA environmental sample collected on October 19, 2010, and finished product samples collected on November 1, 2010, were indistinguishable by both a primary and secondary enzyme; the observed PFGE pattern was also indistinguishable with isolates from environmental and food samples collected by the WSDA in March 2010 and November 2010. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same strain of L. monocytogenes. These PFGE results suggest that L. monocytogenes may have been transported throughout your facility and established niche areas. The presence of a persistent strain of L. monocytogenes in your facility between March 2010 and November 2010, is significant in that it demonstrates that sanitation efforts were inadequate to remove this organism.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
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. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should notify this office in writing, within 15 working days of receipt of this letter, of any corrective actions you have taken to control L. monocytogenes in your facility to prevent contamination of product. You should include any documentation necessary to show that correction has been achieved (e.g., food or environmental monitoring records, revised Standard Sanitation Operating Procedures including any modifications to your cleaning and sanitation operations for surfaces that have a potential to become a niche for L. monocytogenes contamination, etc.). If you cannot complete all corrections within 15 working days, state when the corrections will be completed and the reason for your delay.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any question regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen