| Public Health Service Food and Drug Administration |
| New York District 158-15 Liberty Avenue Jamaica, NY 11433 |
Department of Health and Human Services
July 21, 2010
Warning Letter NYK-2010-24
VIA Vnited Parcel Service
Michael Endico, President
U.F.S. Industries Inc. d.b.a. Sally Sherman Foods
300 N. MacQuesten Parkway
Mount Vernon, NY 10550-1008
Dear Mr. Endico:
We inspected your seafood processing facility, located at 300 N. MacQuesten Parkway, Mount Vernon, NY 10550-1008 between March 29 and April 8, 2010. 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 refrigerated ready-to-eat (RTE) fishery products packed in oxygen-limiting containers including tuna salad, seafood salad, and cream cheese and lox 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 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 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 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 Part 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your HACCP plan that includes your tuna salad, seafood salad, aud cream cheese and lox spread that are packaged in oxygen-liniiting containers, does not list the food safety hazards of Clostridium botulinum growth and toxin formation, allergens, and additionally, for the tuna salad, scombrotoxin (histamine) formation.
Once you have identified these hazards, your HACCP plan must also include appropriate critical control points, establish critical limits, and identify monitoring procedures and record keeping to ensure control of these food safety hazards as required by 21 CFR 123.6(c).
In addition, these products contain allergenic ingredients such as milk, wheat and eggs, which must be declared on finished product labels as required by section 201(qq) of the Act, 21 U.S.C. 321 (qq). Consequently, as are result FDA recommends that firms include a packaging/labeling critical control point in their HACCP plans to conduct a visual check for allergen declarations on each lot of product labels
Furthermore, the oxygen transmission rate of your packaging listed in your package specifications from the packaging manufacturer, (b)(4), is not sufficiently oxygen permeable to create an aerobic environment that will prevent Clostridium botulinum growth and toxin formation. FDA recommends that the minimum oxygen transmission rate of packaging film to ensure prevention of the hazard of Clostridium botulinum growth and toxin formation should be 10,000cc/m2/24 hrs. In the absence of adequately permeable packaging, FDA recommends secondary controls (i.e., in addition to refrigeration) for Clostridium botulinum growth and toxin formation. The use of validated time-temperature integrators on each consumer package is also an appropriate means of providing adequate control. Chapter 13 of the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, can help you determine a method of control that is best suited to your process.
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 Part 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,
a. Your HACCP plan that includes seafood salad does not list the critical control point of:
i. Cooking the scallops for controlling the food safety hazard of pathogen growth and toxin formation.
ii. Post-cook Pre-mix cooling of the scallops for controlling the food safety hazard of pathogen growth and toxin formation.
b. This same HACCP plan includes cream cheese and lox spread and does not list the critical control point of post-cook pre-mix cooling of the lox for controlling the food safety hazard of pathogen growth and toxin formation.
3) You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points 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 HACCP plan that includes cream cheese and lox spread, lists a critica limit, (b)(4) at the cooking critical control point, however the plan does not list whether the temperature limit is for the product internal temperature or the heating media temperature. Additionally, the plan does not list a critical limit for the cooking time required to control the food safety hazard of pathogen growth and toxin production.
4) You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your HACCP plan that includes tuna salad, seafood salad and cream cheese and lox spread lists a monitoring procedure and frequency, (b)(4) with a (b)(4) at the "Cooling/Storage" critical control point that is not adequate to control pathogen growth and toxin formation.
FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated storage. Intermittent temperature checks as a monitoring procedure during refrigerated storage is not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks. FDA also recommends a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly.
5) Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, the corrective action listed in the plan for tuna salad seafood salad, and cream cheese and lox spread, (b)(4) at the "Cooling/Storage" critical control point to control pathogen growth and toxin formation (and histamine formation in tuna salad), is not adequate. Your listed corrective action, does not resolve how the cause of the deviation will be corrected, or ensure that no product enters commerce that is injurious to health or is otherwise adulterated as a result of the deviation.
6) You must verify that your HACCP plan is adequate to control the food safety hazards that are reasonably likely to occur and that the plan is being effectively implemented, to comply with 21 CFR Part 123.8 (a). Specifically, your firm must conduct, or have conducted for you, a scientific study to establish a cooking process for the lox (smoked salmon) ingredient in the your cream cheese and lox spread that ensures that the internal product temperature of all product in each batch will achieve the desired and measured heat exposure required to eliminate pathogens growth and toxin formation. However, during our inspection of-your facility, you stated to the investigator that no validation study was conducted to verify that your cooking process is adequate to control the food safety hazards. FDA recommends establishing, by scientifically validated studies, critical limits for minimum length of cook cycle as a "time" component and minimum critical limit for "temperature" of cooking media, such as water, steam, or oil, in your particular cooking equipment. Other critical factors that affect the heating rate of the product, such as maximum thickness of the smoked salmon trimmings, minimum initial internal temperature of product before presentation to the cooker, and maximum number of pieces placed in the cooker, may also be established by the study. These critical factors would then be established as your critical limits and would be the target of your measured monitoring procedures in your HACCP plan.
7) You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 110.40 (a) and 110.80 (b)(13)(iv). However, you did not monitor prevention of cross-contamination from insanitary objects as evidenced by: On March 30, 2010, our investigator observed a thick white dressing leaking from an overhead product transfer pipe in the finished product packaging room into an open hopper of ready-to-eat coleslaw salad. Furthennore, the thick white dressing was observed to come in contact with black electrical tape (partially covering the leak on the pipe) and old product residue on the pipe before dripping into ready-to-eat coleslaw salad.
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 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. You should include in your response documentation such as HACCP and vetification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
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, the eafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Dean Rugnetta, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo,NY 14202. If you have questions regarding any issues in this letter, please contact Dean Rugnetta at 716-541-0324.
Sincerely,
/s/
Ronald M. Pace
District Director
New York District
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