Inspections, Compliance, Enforcement, and Criminal Investigations
18th Street Deli, Inc
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
August 24, 2010
David L. Salerno, President
18th Street Deli, Inc.
8800 Conant Street
Hamtramck, MI 48211-1401
Dear Mr. Salerno:
We inspected your seafood processing facility, located at 8800 Conant Street, Hamtramck, MI 48211-1401 on April 1-2, 5 and 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 (21 CFR 123). 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 ready-to-eat tuna salad, tuna pasta salad, and fish and cheese sandwich 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 Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge your response received on April 26, 2010 that included a revised HACCP plan and summaries of your corrections. We have provided comments concerning the information below.
Your significant violations were as follows:
1) You must conduct or have conducted 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(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 HACCP plan for “Ready to Eat Products” for fish and cheese sandwiches does not list a critical control point at the “Refrigerated Staging for Shipping” step that is necessary for to control the food safety hazards of pathogens due to time/temperature abuse. Specifically, ready to eat cod and cheese sandwiches are routinely manufactured by your firm and are stored in the Staging/Pack Out Cooler for up to 48 hours prior to shipment to your customers.
Your revised HACCP plan provided with your response dated April 26, 2010 references “Refrigerated Staging” at the same critical control point for “refrigerated storage”. However, there is no information to distinguish between the two critical control points and no evidence that these will be monitored as individual critical control points
2) You must 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(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 HACCP plans do not list the following hazards:
a) “Ready to Eat Products” does not list the food safety hazards of Allergens
b) “Tuna/Tuna Pasta Salad” does not list the food safety hazards of Allergens or Metal fragments.
Your response received on April 26, 2010 does not list the above hazards and does not provide any information to demonstrate control of these hazards identified in the plans above.
3) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm does not consistently maintain temperature monitoring records at the Refrigerated Storage critical control point to control pathogen growth and histamine formation as listed in your HACCP plan for Ready to Eat Tuna Salad and Tuna Pasta Salad. Specifically your firm had no temperature monitoring records for your Main Cooler for January 11 and 13, 2010, February 10, 15 and 17, 2010 while ready to eat tuna salad was being stored there.
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 HACCP plan for “Tuna/Tuna Pasta Salad” lists a monitoring procedure/ frequency at the “Refrigerated Storage and Refrigerated Staging for Shipping” critical control point that is not adequate to control pathogen growth and histamine formation. FDA recommends that reports be reviewed on a daily basis to ensure that the Critical Limit is not exceeded and that the equipment is functioning properly.
We acknowledge that your response received on April 26, 2010, states that the Data Logger will be trended twice a month. Your firm further responded that you will review critical control point monitoring records weekly. We will verify this during the next inspection.
5) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, during the manufacturing of tuna salad on April 5, 2010, your firm was using a white spatula that that had unsmooth surfaces and edges that were frayed, creviced and not easily cleanable and was in direct contact with mayonnaise and salad dressing that was used in the tuna salad. However, your sanitation monitoring records for that same day indicate that these food contact surfaces were acceptable.
6) You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11 (c). However your firm did not maintain adequate sanitation monitoring records for the condition of food contact surfaces required for the processing of tuna salad and/or tuna pasta salad. Specifically, seven of seven sanitation monitoring records reviewed lacked monitoring entries for the condition of food contact surfaces while tuna salad and/or tuna pasta salad was being manufactured on January 4 and 15, 2010, February 3 and 22, 2010, March 5 and 17, 2010 and April 5, 2010. Also, six of the same seven sanitation monitoring records reviewed lacked entries for employee health monitoring. The records are inadequate because the requirements of 21 CFR 123.9(a)(2) and (a)(4) were not present.
We acknowledge that your response received April 26, 2010 states that a new can opener and conveyor belt have been purchased and that the can opener has been added to the pre-operational sanitation inspection log. However; we do not have enough information to ascertain whether you are 1) monitoring sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements, 2) whether you are documenting monitoring and corrections as set out in 21 CFR 123.11(b), or 3) what corrective action was taken to address the spatula and other utensils that the investigator found “not easily cleanable”.
We acknowledge you have included employee health conditions on your pre-operational sanitation inspection log in your response to the observation that you are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for condition and cleanliness of food contact surfaces and control of employee health conditions. However, your response is still inadequate in that your response did not include the condition of food contact surfaces to this inspection log. We request that you provide documentation that this inspection log has been implemented.
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.
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 seafood 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.
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 verification 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.
Please send your reply to the Food and Drug Administration, Attention: Vanessa Colburn, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have questions regarding any issues in this letter, please contact Ms. Colburn at 313-393-8121.
Joann M. Givens
Detroit District Office