Uoya Inc. dba Shintoku, Inc. 12/22/15
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
December 22, 2015
WARNING LETTER NYK-2016-15
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Nobuaki Ishida, President
dba Shintoku, Inc. & Apollo Fish Co.
1241 Viele Avenue
Bronx, NY 10474-7127
Dear Mr. Ishida:
We inspected your seafood processing facility, located at 1241 Viele Avenue, Bronx, NY 10474-7127 on July 6, 7 & 9, 2015.
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 Part 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 “Big Eye Tuna Loins”, “Vacuum-Packaged Farmed Raw Yellowtail Fillets with time-temperature indicators”, Fresh Striped jack” and “Fresh Mackerel” are You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance: Fourth Edition through links in FDA's home page at www.fda.gov.
adulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health.
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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for:
- Vacuum packaged raw farmed yellowtail fillets packaged with Time Temperature Indicators (TTIs) to control the hazards of scombrotoxin (histamine) formation, Clostridium botulinum toxin formation, and pathogenic bacteria growth and toxin formation;
- Fresh mackerel to control the hazards of scombrotoxin (histamine) formation, parasites, and pathogenic bacteria growth and toxin formation, for product intended for raw consumption; and
- Fresh striped jack to control the hazard of scombrotoxin (histamine) formation, parasites, and pathogenic bacteria growth and toxin formation for product intended for raw consumption.
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 HACCP plan for Tuna does not list the critical control point of unrefrigerated processing consisting of manual cutting of loins, weighing, staging and packing for controlling the food safety hazard of scombrotoxin (histamine) formation.
3. 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 lists monitoring procedures/frequencies at the (b)(4) and (b)(4) critical control points that are not adequate to control scombrotoxin (histamine) formation. Specifically, your monitoring procedures do not ensure conformance with your critical limits for time and temperature of exposure. In general, FDA recommends that firms establish a critical limit for the temperature of the cooler during refrigerated storage rather than a critical limit for time of exposure to temperatures above 40°F. However, because you chose to monitor the time of exposure to temperatures above 40°F during storage, FDA recommends that you make visual observations of the length of time of product exposure to unrefrigerated conditions (i.e., above 40°F (4.4°C)) at least every 2 hours and that you measure ambient air temperature (in this case the cooler temperature), using a continuous temperature-recording device (e.g., a recording thermometer) and that continuous monitoring during storage is accomplished by the device itself, with a visual check of the recorded data at least once per lot or batch, but no less often than once per day.
4. 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, your corrective action plan for Tuna at the:
- (b)(4) critical control point to control scombrotoxin (histamine) formation is not appropriate. Specifically, the corrective action plan does not ensure that the cause of the deviation is corrected. FDA recommends that in addition to rejecting the lot you discontinue use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.
- (b)(4) and (b)(4) critical control points to control scombrotoxin (histamine) formation is not appropriate. Specifically, the corrective action plan does not ensure that no adulterated product enters commerce or that the cause of the deviation is corrected. In general, FDA recommends that firms establish a critical limit for the temperature of the cooler during refrigerated storage rather than a critical limit for time of exposure to temperatures above 40°F. However, because you chose to monitor the (b)(4) during storage, when a deviation from a critical limit for (b)(4) occurs, FDA recommends that you:
o Chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot. Destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50 ppm. The fish collected for analysis may be composited if the action plan is reduced accordingly. For example, a sample of 60 fish may be composited into 20 units of 3 fish each, provided the action point is reduced from 50 ppm to 17 ppm for each unit;
o Destroy the product;
o Divert the product to a non-food use.
o Add ice to the product;
o Return the affected product to the cooler;
- Modify the process as needed to reduce the time and temperature exposure.
5. 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 HACCP plan for Tuna does not list the food safety hazard(s) of pathogen growth and toxin formation.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Your monitoring procedures at the (b)(4) critical control point indicates that you will monitor the (b)(4) at the time of delivery by (b)(4) of the (b)(4) of (b)(4) received and that you will monitor the (b)(4) using a (b)(4) or (b)(4) in a (b)(4) of (b)(4) received. FDA recommends that you monitor the adequacy of ice by making visual observations of the adequacy of ice surrounding the product in a representative number of containers (e.g., cartons and totes) from throughout the shipment, at delivery for every lot received, that you monitor the adequacy of cooling media by making visual observation of the adequacy and frozen state of cooling media in a representative number of containers (e.g., cartons and totes) from throughout the shipment for every lot received, and that you monitor the internal temperature of the fish in a representative number of fish from throughout the shipment for every lot received.
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 importer verification records and records that document the performance and results of your firm’s affirmative steps, 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 seafood establishment operates in compliance with the Act and the seafood HACCP regulation (21 C.F.R. 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 for the fish or fishery products that you process.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent to Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or by e-mail at Lillian.Aveta@fda.hhs.gov
Ronald M. Pace
New York District