| Public Health Service Food and Drug Administration |
Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
August 8, 2011 WL 51-11
Mr. Rene D. Rivero, President
Kimriv Restaurant Group, LLC.
2876 Main Street, San Diego
CA, 92113-3729
Dear Mr. Rivero:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 2876 Main Street, San Diego, CA on April 13-20th, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly, your fishery products such as your pasteurized crab meat, scombroid species of fish, shrimp and various other fish and fishery products including the products that are manufactured from these fish and fishery products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the current 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s revised HACCP plan provided with your May 9, 2011 response and entitled “HACCP Plan #2 - Pasteurized Canned Crabmeat” does not identify the food safety hazard of Clostridium botulinum growth and toxin formation at the “Receiving” critical control point.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “Point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s revised HACCP plans submitted with your May 9th response and entitled
a) “HACCP Plan #1 - Scombroid Suspable [sic susceptible] Fish” does not list the critical control point of “thawing” for controlling the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum or scombrotoxin formation and parasites;
b) “HACCP Plan #3 - Shrimp” does not list a critical control point of “thawing” for controlling the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum;
c) “HACCP Plan #4 - Seafood Other Than HACCP #1&2&3” does not list the critical control point of “processing” for controlling the food safety hazards of pathogen growth and toxin formation, including Listeria monocytogenes, and parasites.
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s revised HACCP plans submitted with your May 9th response entitled
a) “HACCP Plan #2 – Pasteurized Canned Crabmeat” and “HACCP Plan #3 – Shrimp” list a critical limit of (b)(4) at the “Processing (CCP#3)” critical control point that is not adequate to control pathogen growth and toxin formation. Variations in temperatures above 40°F can affect acceptable exposure times and may permit the rapid growth of pathogens. In some instances, (b)(4) at excessive temperatures can be potentially unsafe. Maintaining temperatures as close to 40°F as possible will prevent potential pathogen growth. However, since your firm is intending to permit exposures to temperatures above 40°F, FDA recommends the following time and temperature parameters: For example:
a. If at any time the product is held at internal temperatures above 80°F, exposure time should be limited to 1 hour. Or,
b. If at any time the product is held at internal temperatures above 80°F, exposure time should be limited to 4 hours, as long as no more than 1 of those hours is above 70°F.
For additional information related to unrefrigerated processing controls, please see page 234 of the 4th Edition of the Hazard Guide.
b) “HACCP Plan #3 – Shrimp” lists a critical limit of (b)(4) at the “CCP – 5 (Receiving)” critical control point that is not adequate to control the presence of sulfites in incoming shrimp. Your firm should list the controls in your plan which will assure that information on previously labeled products you receive is carried over to your finished product label.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan submitted with your May 9th response and entitled
a) “HACCP Plan #1 - Scombroid Suspable [sic susceptible] Fish” lists monitoring frequencies at the “Refrigerated Storage” critical control point that are not adequate to control pathogen growth and toxin formation or histamine formation. FDA recommends continuous monitoring and recording of temperatures with a visual check of recorded data at least once per day.
b) “HACCP Plan #2 - Pasteurized Canned Crabmeat”, “HACCP Plan #3 - Shrimp”, and “HACCP Plan #4 – Seafood Other Than HACCP #1&2&3” list monitoring frequencies at the “Refrigerated Storage” critical control point that are not adequate to control pathogen growth and toxin formation. FDA recommends continuous monitoring and recording with a visual check of recorded data at least once per day.
c) “HACCP Plan #1 – Scombroid Suspable [sic susceptible] Fish”, “HACCP Plan #2 – Pasteurized Canned Crabmeat”, HACCP Plan #3 – Shrimp” and “HACCP Plan #4 – Seafood Other Than HACCP #1&2&3” lists monitoring frequencies at the “Packaging-Labeling” critical control point that are not adequate to control allergens. FDA recommends label review at the beginning of production of each lot and every hour thereafter.
5. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans included in the plans provided with your May 9th response are not appropriate for:
a) “HACCP Plan #1 - Scombroid Suspable [sic susceptible] Fish”, “HACCP Plan #3 - Shrimp” and “HACCP Plan #4 - Seafood Other Than HACCP #1&2&3” at the Refrigerated Storage, Processing and Packaging-Labeling critical control points and;
b) “HACCP Plan #2 - Pasteurized Canned Crabmeat” at the “Receiving, Refrigerated Storage, Processing and Packaging-Labeling” critical control points.
A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that (1) no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation and (2) that the cause of the deviation is corrected. The corrective actions you have listed in these HACCP plans do not provide these assurances.
Additional comments:
FDA collected environmental swabs at various locations in your facility and found that 29 of 60 swabs tested positive for various strains of Listeria in a processing area where ready to eat (RTE) items such as your canapés, hors d’oeuveres, and sushi rolls are produced. The presence of Listeria spp. was also found on the cutting board table, which shows that the insanitary conditions resulted in the contamination of a food contact surface.
The presence of non-pathogenic forms of Listeria spp., e.g., L. innocua and L. welshimeri, in the environment and on a food contact surface should alert a processor to the potential contamination of ready-to-eat product during processing. The Listeria spp. are used as indicators of contamination because they are found more frequently than L. monocytogenes. The presence of any Listeria spp. suggests that conditions also are suitable for survival and/or growth of L. monocytogenes.
Moreover, L. monocytogenes was found on the floor under the slicer table. Strict in-plant sanitation measures must be instituted to eliminate the organism or prevent the proliferation in the plant.
Additionally, you included copies of environmental swab test results that were taken to verify cleaning and sanitation conducted in response to the positive samples collected. You also included a copy of your new Listeria Testing Program (LTP). We acknowledge that the swabs you collected were found negative for Listeria. However, we find your response inadequate. Your LTP states that swabs of food contact surfaces will be sent to an outside lab to be tested for Listeria species. According to your LTP if you find a positive swab you do not further differentiate the species to determine if the species is Listeria monocytogenes and/or require testing of potentially affected finished products.
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on 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 request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective action, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
Blake Bevill
Director Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
Cc:
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
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