Inspections, Compliance, Enforcement, and Criminal Investigations
River Ranch Fresh Foods, LLC 3/27/12
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
March 27, 2012
Bruce N. Knobeloch, President.
River Ranch Fresh Foods, LLC.
1156 Abbott Street
Salinas, CA 93901
Dear Mr. Knobeloch:
The Food and Drug Administration (FDA) conducted an inspection of your fresh produce processing facility, located at 1085 Abbott Street, Salinas, CA, from October 13-26, 2011. The inspection was conducted in response to a sample of "The Farmer's Market" brand shredded lettuce collected and analyzed by the State of Ohio, Department of Agriculture under the United States Department of Agriculture (USDA) Microbial Data Program (MDP) that yielded Listeria monocytogenes (L. monocytogenes) a human pathogen. This sample of shredded lettuce was produced at your Salinas facility on or about September 27, 2011.
During our October 13-26, 2011 inspection FDA collected environmental and finished product samples. Subsamples collected from the floors of the barrel wash room and the raw material cooler storage room yielded a strain of L. monocytogenes that is indistinguishable by Pulsed Field Gel Electrophoresis (PFGE) from the strain isolated by the State of Ohio from your shredded lettuce. Our investigators also documented violations of FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations, Title 21 of the Code of Federal Regulations (CFR) Part 110 (21 CFR Part 110). Based on the conditions observed during the inspection and the finding of L. monocytogenes at your facility, products processed at your Salinas facility are 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 they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to heath.
We also conducted an inspection at your fresh produce processing facility located at 175 N. First St. in El Centro, California from January 24-27, 2012 in response to findings of L. monocytogenes in a sample of romaine lettuce collected by the Canadian Food Inspection Agency (CFIA) in December of 2011. The romaine tested by CFIA originated from your El Centro facility. During the inspection of your El Centro facility our investigators documented violations of FDA's CGMP regulations for human food (21 CFR Part 110), that render products processed at this facility adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
The following violations were observed at your Salinas facility:
• Your plant and facilities must be constructed in such a way to facilitate maintenance and sanitary operations for food-manufacturing purposes to meet the requirements of 21 CFR 110.20(b). Specifically, your plant and facilities must be constructed in such a manner as to allow the floors to be adequately cleaned and kept clean and kept in good repair, to meet the requirements of 21 CFR 110.20(b)(4). Our inspection found chipped and damaged concrete floors with standing water in the barrel wash (and QC station) room, inside the main forklift entrance into the salad room, and at the forklift entrance to your raw material cooler storage room. FDA environmental samples were positive for L. monocytogenes from the floors of the barrel wash room and the raw material cooler storage room.
The following violations were observed at your El Centro facility:
• All persons working in direct contact with food must conform to hygienic practices including washing of hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) at any time when the hands may have become soiled or contaminated, to comply with 21 CFR § 110.10(b)(3). However, our investigator observed an employee with a blue cap i.e. an employee designated for direct contact with food, carrying a red broom and red shovel (utensils designated for trash and cleaning) proceed to handle ready-to-eat food. The employee was never observed washing and sanitizing his hands prior to contacting ready-to-eat food.
• You must clean and sanitize equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, to meet the requirements of 21 CFR § 110.35(a). However, our investigator observed plant residues on the surface of three sieve components of shaker tables, on the conveyor belt of an elevator, and on electrical and control panels. This organic matter may harbor pathogens, including, but not limited to L. monocytogenes.
The above violations are not meant to be an all-inclusive list of violations at your facilities. It is your responsibility to ensure that all of your products are in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
In addition, we note that, in January 2010, River Ranch Fresh Foods sent thirty-four (34) retained product samples and thirty (30) environmental samples from your El Centro facility to a private laboratory in response to a CFIA sample of Compliments Brand Italian Blend Salad Mix which yielded L. monocytogenes. Three (3) samples of your retained product and eight (8) environmental samples, a total of eleven (11), yielded L. monocytogenes. FDA collected the eleven (11) isolates from the private laboratory and conducted a PFGE analysis. Based on our analyses, all eleven (11) isolates have a PFGE pattern indistinguishable from the sample of shredded lettuce analyzed by the State of Ohio and indistinguishable from our environmental samples (see first and second paragraphs).
We note that you transfer personnel and equipment between the two facilities seasonally. Taken together, the recovery of L. monocytogenes with indistinguishable PFGE patterns from product and environmental samples collected from January 2010 to October 2011 that originated from your El Centro and Salinas facilities indicates that the cleaning and sanitizing practices you employ have not been effective to control L. monocytogenes. In our Draft Guidance for Industry, "Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods," we recommend a number of practices to control L. monocytogenes. Specifically, we recommend that you establish and implement a written plan for the collection of environmental samples from critical surfaces and areas, and for testing those samples for the presence of Listeria species or L. monocytogenes. We recommend that you evaluate each plant, product, and process to determine the appropriate monitoring points. You may find our draft guidance for the control of L. monocytogenes by following links for industry guidance and Listeria at www.fda.gov
We acknowledge corrections that you made prior to the end of the inspections. We also acknowledge your October 31, 2011 and your February 8, 2012 responses to the FDA 483s for your Salinas and El Centro facilities, respectively, in which you outlined corrections that you had made or would make. However, your responses are inadequate because they did not provide documentation of these corrections.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
We also believe that meeting to discuss these issues would be beneficial to your firm and the FDA. A meeting would provide an opportunity for you to ask questions you may have regarding the implementation of your corrections and any measures you are taking to adequately control L. monocytogenes in your processing environment and to come into, compliance with the Act.
Please send your response to the Food and Drug Administration, Attention: Darlene B. Almogela, Director, Compliance Branch,. 1431 Harbor Bay Parkway, Alameda, CA 94501. Please contact Russell A. Campbell, Compliance Officer at (510) 337-6861 to schedule the requested meeting. You may also contact Mr. Campbell if you have any questions regarding this letter.
Barbara J. Cassens