Inspections, Compliance, Enforcement, and Criminal Investigations

Monte's Seafood Emporium, Inc. 1/19/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District 
158-15 Liberty Avenue
Jamaica, NY 11433 
(718) 340-7000

 

January 19, 2016
 
WARNING LETTER NYK-2016-1
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Richard F. Montelbano, President
Monte’s Seafood Emporium, Inc.
800 Food Center Drive, Unit #27
Bronx, N.Y. 10474
 
Dear Mr. Montelbano;
 
We inspected your seafood processing facility, located at 800 Food Center Drive, Unit #27, Bronx, N.Y. 10474 on March 2, 3 &10, 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 “Pasteurized Ready-To-Eat Crab Meat,” “Frozen Vacuum Packed Yellowtail Snapper,” and “King Mackerel” areadulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. 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.
 
Your significant violations were as follows:
 
1.    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 HACCP plan for:
 
a.    “Pasteurized Ready to Eat Canned Crab Claw Meat,” lists critical limits of “(b)(4)" to control pathogen growth and toxin formation, including Clostridium botulinum toxin formation because these limits do not ensure that the products are continuously maintained at adequate temperatures.  FDA recommends that: "at the “(b)(4)” critical control point and “(b)(4)” at the “(b)(4)” critical control point that are not adequate
  • For products delivered under refrigeration: All lots received are accompanied by transportation records that show that the product was held at or below 40°F (4.4°C) throughout transit;
OR
  • For products delivered under ice: Product is completely surrounded by ice at the time of delivery;
OR
  • For products delivered under chemical cooling media, such as gel packs: There is an adequate quantity of cooling media that remain frozen to have maintained product at 40°F (4.4°C) or below throughout transit AND the internal temperature of the product at the time of delivery is 40°F (4.4°C) or below;
OR
  • For products delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less: Time of transit does not exceed 4 hours AND the temperature of the product at the time of delivery does not exceed 40°F (4.4°C).
 
In addition, FDA recommends that for refrigerated storage: The product is held at a cooler ambient temperature of 40°F (4.4°C) or below.
 
b.    “Raw Fish Histamine Group” lists critical limits of, “(b)(4) because these limits do not ensure that the products are continuously maintained at adequate temperatures.  FDA recommends that:” at the “(b)(4)” critical control point, “(b)(4)” at the “(b)(4)” critical control point, and “(b)(4)” at the “(b)(4)” critical control point, that are not adequate to control histamine formation
  • For fish delivered refrigerated (not frozen): All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit;
OR
  • For fish delivered under ice: Fish are completely surrounded by ice at the time of delivery;
OR
  • For fish delivered under ice on an open-bed truck: Fish are stored completely surrounded by ice AND the internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
OR
  • For fish delivered under chemical cooling media such as gel packs: There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit AND The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
OR
  • For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy): Time of transit does not exceed 4 hours AND internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).
 
In addition, FDA recommends that for product stored under ice (including during display): The product is completely and continuously surrounded by ice throughout the storage time.
 
c.    “Vaccume Pack Group” lists critical limits of, “(b)(4) because these limits do not ensure that the products are continuously maintained at adequate temperatures.  For vacuum packaged smoked, salted, or pickled products, FDA recommends that: ” at the “(b)(4)” critical control point, “(b)(4)” at the “(b)(4)” critical control point, and “(b)(4)" at the “(b)(4)” critical control point that are not adequate to control Clostridium botulinum toxin formation
  • For products delivered under refrigeration: All lots received are accompanied by transportation records that show that the product was held at or below 40°F (4.4°C) throughout transit;
OR
  • For products delivered under ice: Product is completely surrounded by ice at the time of delivery;
OR
  • For products delivered under chemical cooling media, such as gel packs: There is an adequate quantity of cooling media that remain frozen to have maintained product at 40°F (4.4°C) or below throughout transit AND the internal temperature of the product at the time of delivery is 40°F (4.4°C) or below;
OR
  • For products delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less: Time of transit does not exceed 4 hours AND the temperature of the product at the time of delivery does not exceed 40°F (4.4°C). 
For vacuum package products bearing activated Time-Temperature Indicators (TTIs), FDA recommends following the same guidance as indicated above except that where the critical limits list "(b)(4)” they should list 38°F (3.3°C).
 
 In addition, FDA recommends that for products stored under ice (including during display), the product is completely and continuously surrounded by ice throughout the storage time.
 
Once you have revised your HACCP plans to incorporate the above FDA critical limit recommendations, you must establish and implement monitoring procedures and frequencies to assure that these critical limits are met at each critical control point, to comply with 21 CFR 123.6 (b) and (c)(4). This includes the maintenance of all monitoring records.
 
2.    Because you chose to include corrective actions in your HACCP plans, your described corrective action plans must be appropriate, to comply with 21 CFR 123.7(b).  However, your corrective actions plans are not appropriate.  Specifically,
 
a.    Your corrective action plan for “Pasteurized Ready to Eat Canned Crab Claw Meat” at the “(b)(4)” critical control point does not ensure that the cause of the deviation is corrected.  FDA recommends that in addition to "(b)(4) you discontinue the use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.
 
b.    Your corrective action plans for “Raw Fish Histamine Group” at the “(b)(4),” and “(b)(4)” critical control points do not ensure that no adulterated product enters commerce and/or that the cause of the deviation is corrected.  Specifically,
 
i.      At the “(b)(4)” critical control point, FDA recommends that you chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including any with temperatures that exceeded a critical limit, and any fish observed to have been exposed to inadequate cooling media (or the entire lot for lots smaller than 60 fish); reject the lot if any fish is found with histamine greater than or equal to 50 ppm or reject the lot and discontinue the use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.
 
ii.      At the “(b)(4)” and “(b)(4)” critical control points, FDA recommends that in addition to icing or re-icing the product, you chill and hold the product until it can be evaluated based on its total time and temperature exposure, or chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including any with temperatures that exceeded a critical limit, and any fish observed to have been exposed to inadequate cooling media (or the entire lot for lots smaller than 60 fish); reject the lot if any fish is found with histamine greater than or equal to 50 ppm, or destroy the product and you make adjustments to the ice application operations.
 
c.    Your corrective action plans for “Vaccume Pack Group” at the “(b)(4),” and “(b)(4)” critical control points do not ensure that adulterated product does not enter commerce and/or that the cause of the deviation is corrected. Specifically,
 
i.    At the “(b)(4)” critical control point, FDA recommends that you chill and hold the affected product until an evaluation of the total time and temperature exposure is performed, or reject the lot and discontinue the use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.
 
ii.    At the “(b)(4)” and “(b)(4)” critical control points, FDA recommends that in addition to icing or re-icing the product, you chill and hold the affected product until an evaluation of the total time and temperature exposure is performed, or destroy the product and make adjustments to the ice application operations.
 
Your firm’s responses received via electronic mail on March 18, 2015 and April 27, 2015 list that you plan to install monitors for your coolers and to communicate with your trucking companies to ensure your products are maintained at proper temperatures. Your responses also list that you plan to send two employees for HACCP training in June, 2015 and revise your HACCP plans.  However, to- date, we have not received any further communications regarding specific corrective actions taken to the objectionable conditions noted, such as revised HACCP plans.
 
We may take further action if you do not promptly correct these violations. For instance, we may take action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on “detention without physical examination,” or seize your product(s) and/or enjoin your firm from further violating the Act.
 
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 importer 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 import into the United States.
 
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.
 
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District
 

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