| Public Health Service Food and Drug Administration |
| Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human Services
June 13, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-16
Sally A. Jackson, Owner
Sally Jackson Cheeses
16 Nealey Road
Oroville, Washington 98930
WARNING LETTER
Dear Ms. Jackson:
The U.S. Food and Drug Administration (FDA) inspected your cheese processing establishment, located at 16 Nealey Road, Oroville, Washington, on December 15-17, 2010. On December 10, 2010, we collected sample 664001, consisting of wheels of aged cow milk cheese wrapped in chestnut leaves; laboratory analysis of this sample found the pathogen E. coli O157:H7. FDA also collected Sample 593566, on December 15, 2010, consisting of wheels of aged raw goat milk cheese wrapped in grape leaves; laboratory analysis of this sample found the pathogen Listeria monocytogenes (L. monocytogenes). As evidenced by these sample results, your cheese products were adulterated within the meaning of Section 402(a)(1) of the Act, [21 U.S.C. § 342(a)(1)], of the Federal Food, Drug, and Cosmetic Act (the Act), in that your cheeses contain a poisonous or deleterious substance which may render them injurious to health.
Laboratory analysis using pulsed-field gel electrophoresis (“PFGE”) found that the E. coli O157:H7 isolate obtained from your aged cow milk cheese (Sample 664001), was indistinguishable from a strain of E. coli O157:H7 that caused an outbreak of human illness, which was investigated by the Oregon Public Health Department (OPHD), Washington State Department of Agriculture (WSDA), and the Washington Department of Health (WDOH).
On December 15, 2010, we also collected Sample 593565 consisting of two sets of 48 environmental swab subsamples taken from surfaces of various locations in your processing facility. The results of the analyses of these environmental swabs found L. monocytogenes from the floor of your cheese room. Analysis using PFGE showed that the L. monocytogenes isolate obtained from the environmental sample from your cheese room floor (Sample 593565), and finished product cheese (Sample 593566) were indistinguishable by both a primary and secondary enzyme. 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 and the pathogen may have been transported throughout your facility. Based on these findings and inspectional observations, your cheese products were adulterated within the meaning of Section 402(a)(4) of the Act, [21 U.S.C. § 342(a)(4)], of the Federal Food, Drug, and Cosmetic Act (the Act), in that your cheese had been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or been rendered injurious to health. You may find the Act through links in FDA's home page at www.fda.gov.
A report of the analytical results of Samples 593566 and 593565 were mailed to you by our Pacific Regional Laboratory-Northwest on January 5, 2011.
E. coli O157:H7
E. coli O157:H7 is a virulent strain of shiga toxin-producing E. coli (STEC). Illness caused by this pathogen is usually characterized by diarrhea (often bloody), abdominal pain and fever sometimes. E coli O157:H7 cause hemorrhagic uremic syndrome (HUS) which is associated with chronic kidney failure especially in young children. All people are susceptible but the illness is more sever in the elderly, infants, children and the immunocompromised individuals. The primary reservoir of this pathogen is the bovine intestinal tract and udders, and contamination may occur through water supplies and foods through feces and milk respectively. Raw milk is one of most frequent vehicles for the infection and E coli O157:H7 has been implicated as the causative agent in outbreaks involving milk and milk products such as cheese. E coli O157:H7 can survive in highly acidic environment, refrigeration temperatures and saline. Aside from raw milk contamination, post processing contamination including cross contamination pose as a potential health hazard to consumers. Milk pasteurization has been shown to destroy the pathogen and the application of good manufacturing practices in the processing environment to ensure sanitary conditions will reduce the risk of food product contamination by this organism.
L. monocytogenes
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.
We acknowledge the receipt of your response to the FDA Form 483-Inspectional Observations, on December 29, 2010. The FDA Form 483 documented serious deviations from the Current Good Manufacturing Practices (CGMP) requirements specified in Title 21, CFR Part 110. We have the following comments based on your response:
(1) Employees must take precautions such as washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. Your response does not provide documentation of corrective actions you have taken (e.g., employee training, revised Sanitation Standard Operating Procedures (SSOPs), etc.) to ensure employees use proper hand washing practices during cheese manufacturing operations.
(2) Cleaning and sanitizing of non-food-contact surfaces should be conducted as frequently as necessary to protect against contamination of food. Your response does not provide information of corrective actions you have taken (e.g., employee training on proper cleaning and sanitation of walls, floors and other non-floor contact surfaces, revised SSOPs, etc.) to ensure that cleaning and sanitizing procedures are effective to remove product residues, dirt and grime on floors, walls and other non-food contact surfaces, and that it is conducted in a manner that does not contribute to contamination of food or food contact surfaces. We note that FDA investigators observed mud, manure, straw and wood chip debris on the floor of the cheese room and FDA’s environmental sample (Sample 593565) confirmed the presence of L. monocytogenes from the floor of the cheese room near the stove.
(3) Buildings, fixtures, and other physical facilities of the plant must be maintained in a sanitary condition and kept in repair sufficient to prevent food from becoming adulterated. Your response does not provide documentation of corrective actions you have taken (i.e., completed facility upgrades such as the new roof to address water leaks, repairs of holes, cracks and peeling paint/plaster on walls, and repairs to cracked and pitted floors observed to have pooling water) to ensure that the condition of the plant does not contribute to contamination of foods.
(4) Employees who work in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty and wear suitable outer garments that protect against contamination. Your response does not provide documentation of corrective actions you have taken (e.g., revised SSOPs, employee training on how you will minimize contamination from milking and outdoor activities to indoor processing areas, and when employees are to change soiled garments to reduce the potential for manure to contact foods or food contact surfaces).
(5) Equipment and utensils must be designed and made of materials that allow for proper cleaning. Your response does not provide documentation of corrective actions you have taken to replace or fix broken and cracked cheese molds used in cheese making. In addition, the use of wood as a food-contact surface has limited applicability in food processing, as its use depends on nature of the food and the type of wood used. Surfaces that are unable to be routinely cleaned and sanitized because of the materials used could harbor foodborne pathogens. Moreover, deterioration of wooden surfaces of equipment such as pitting may inhibit adequate cleaning of the surfaces of equipment, so that food in contact with the equipment may become contaminated.
(6) You must take necessary precautions to protect against contamination of food, food contact surfaces, and food packaging systems with microorganisms and foreign substances. Your response does not provide information of corrective actions you have taken (e.g., employee training on proper use and storage of insanitary objects, such as garden hoses on the floor, etc.) to ensure that employee practices do not contaminate food or food contact surfaces.
(7) Persons working in direct contact with food, food-contact surfaces, and food packaging materials must store clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed. Your response does not provide information of corrective actions you have taken (e.g., employee training or revised SSOPs) on proper use and storage of items such as hats, coats, dirty work gloves and cheese cloths, and other personal belongings.
You should respond within fifteen (15) working days from your receipt of this letter. We acknowledge you have posted on your website at www.sallyjacksoncheeses.com that you closed your doors in December 2010. Please advise FDA of your current operating status. If your firm is operational, you are responsible for ensuring that your processing plant operates in compliance with the Act and applicable regulations. You should notify this office in writing of any corrective actions, including an explanation of each step being taken to prevent the recurrence of similar conditions at that time. Include any documentation necessary to show that correction has been achieved. We may take further action if you resume operations and fail to correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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.
Sincerely,
/S/
Charles M. Breen
District Director
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