Inspections, Compliance, Enforcement, and Criminal Investigations

Halperns' Steak & Seafood Company LLC 11/17/15

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204·3128 

 

November 17, 2015           
 
2015-DAL-WL-03
 
                                               
WARNING LETTER
                                                                                   
UPS OVERNIGHT                                                             
 
 
Howard Halpern, Chairman and CEO
James R. Hicks, President-COO
Halperns’ Steak and Seafood Company, LLC.
4685 Welcome All Road
Atlanta, Georgia 30349
                                                                                               
Dear Mr. Halpern and Mr. Hicks,
 
We inspected your seafood processing facility, located at 2158 W. Northwest Hwy, Suite 410, Dallas, Texas, on September 22, 2015 through October 2, 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 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 canned pasteurized crabmeat, histamine forming fish, and caviar 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, Fourth Edition (HACCP Guide) 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 (CCP) to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for caviar lists critical limits at theReceiving critical control point (CCP) that are not adequate to control pathogen growth and toxin formation, including Clostridium botulinum.
 
Specifically, your Receiving CCP lists critical limits of “Caviar containers are cooled with (b)(4) [and] Ambient temperature of product is (b)(4)°F or below at delivery”. These critical limits are inadequate to control the hazards associated with the product. Specifically, your critical limit does not include: 1) both the quantity of (b)(4) to be adequate and the internal temperature of the product to be taken at the time of delivery, or 2) the internal temperature of the product must be less than (b)(4)°F throughout transit or all lots received with transportation records showing product was held at less than (b)(4)°F throughout transit; or 3) the documented transit time for the product (including all time outside of a controlled environment) was less than (b)(4) hours and the internal temperature was less than (b)(4)°F at receipt.
 
We have reviewed your response dated October 14, 2015 and determined it is inadequate. Your response asserts caviar is not a fishery product; however, “fish” and “fishery product” are defined in 21 CFR 123.3(d) and 123.3(e). These definitions specifically include the roe of finfish and other aquatic animals. Additionally, your canned caviar does have associated hazards and requires an adequate HACCP plan be implemented. 
 
Additionally, your revised unsigned HACCP plan for histamine forming fish submitted with your response included a revision to the critical limit at your Cold Storage CCP. Your revised critical limit states “ OR Ambient cooler temperature must not exceed (b)(4)°F (b)(4)”. Critical limits during refrigerated storage that specify a cumulative time and temperature of exposure to temperatures above (b)(4)°F are not ordinarily suitable because of the difficulty in tracking the specific products and the specific cumulative temperature exposures that those products experience.
 
2.    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;
 
a.    Your corrective action plan for caviar at the Receiving CCP to control Clostridium botulinum and pathogens is not appropriate. Your corrective action should evaluate and correct deviations that exceed your critical limit; however, your corrective action plan does not address caviar that is received without adequate (b)(4). Your HACCP plan does not include monitoring of the truck throughout transit. Therefore you should not use the temperature of the truck at receipt as adequate justification to accept a lot that did not meet your critical limit for (b)(4).
 
b.    Your corrective action plan for histamine forming fish at the “Receiving with (b)(4)” CCP to control histamines is not appropriate. Your corrective action should evaluate and correct deviations to your critical limit; however, your corrective action does not address finfish that is received without adequate (b)(4). Your HACCP plan does not include monitoring of the truck throughout transit. Therefore you should not use the temperature of the truck at receipt as adequate justification to accept a lot that did not meet your critical limit for (b)(4).
 
We have reviewed your response dated October 14, 2015 and determined it is inadequate and does not address this deviation. 
 
Additionally, your revised unsigned HACCP plan for histamine forming fish submitted with your response included a revision to the corrective action plan at the Receiving CCP. Your corrective action plan only addresses if the truck temperature exceeds (b)(4)°F at receipt. This is not an adequate corrective action plan. Corrective action should be taken any time a critical limit is exceeded.
 
Additionally, your revised unsigned HACCP plan for histamine forming fish submitted with your response included a revision to the corrective action plan at the Storage CCP. Your corrective action plan associated with your ambient cooler temperature critical limit states to reject the fish if the internal temperature exceeds (b)(4)°F. This is not an adequate corrective action because it only addresses the temperature of the product at the time of measurement and does not address total time and temperature exposure of the product.
 
Additionally, your revised unsigned HACCP plan for histamine forming fish submitted with your response included a new “Processing” CCP. Your corrective action states to reject the fish if the internal temperature exceeds (b)(4)°F. This is not an adequate corrective action because it only addresses the temperature of the product at the time of measurement and does not consider total time and temperature exposure of the product.
 
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 histamine forming fish lists a monitoring frequency at the Storage CCP that is not adequate to control histamines.
 
Specifically, your firm’s HACCP plan for histamine forming fish lists a monitoring procedure to monitor the adequacy of ice (b)(4). The monitoring frequency is inadequate under your current processes. Your firm removes fish from the cooler for processing and does not replace ice on unprocessed fish to ensure it is completely surrounded by ice. Our investigator observed your firm conducts your ice monitoring (b)(4); however, you remove the fish from the cooler (b)(4). Our investigator observed inadequate ice in bulk plastic containers of tuna on September 22 and 24, 2015 at 10:30 AM and 9:45 AM, respectively. These observations were made after your firm conducted your ice monitoring (b)(4).
 
We have reviewed your written response to the FDA 483, Inspectional Observations, dated October 14, 2015 and have determined it is inadequate. Your response states you have revised your HACCP plan to require ice monitoring (b)(4). However, your response does not address what process controls have been put into place to ensure that (b)(4) monitoring is adequate.
 
Additionally, your revised unsigned HACCP plan for histamine forming fish submitted with your response included a revision to the monitoring procedures for the Receiving CCP. The monitoring procedure states you will monitor for “Adequate ice coverage or (b)(4)”. This monitoring procedure is not adequate to monitor the critical limit of “Product received in conveyance with adequate ice”. Products received on (b)(4) would require a different critical limit and monitoring to include measurement of the internal temperature of the product at receipt and adequacy of a sufficient number of (b)(4).
 
4.    You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a).
 
Your firm did not take a corrective action to control the food safety hazard of Clostridium botulinum when your process for canned pasteurized crabmeat deviated from your critical limit at the Receiving CCP of your HACCP plan for “Pasteurized blue crabmeat” dated July 6, 2015 and unrevised since November 20, 2014. Your critical limit states “Truck temperature was maintained at (b)(4)°F or below during shipping”. On July 27, 2015 your firm received a shipment of canned pasteurized blue crabmeat that exceeded (b)(4)°F, up to approximately (b)(4)°F for approximately (b)(4) hours during transit. Your firm did not take any corrective actions for these critical limit deviations and this product was subsequently distributed.
 
We have reviewed your written response to the FDA 483, Inspectional Observations, dated October 14, 2015 and have determined it is inadequate. Although you have stated you have purchased more accurate time-temperature recorders and conducted a recall of the specific product identified in the observation, you did not assess other shipments received under the same process to determine if other product was released without appropriate corrective actions being taken.
 
5.    To comply with 21 CFR 123.10, you must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing that is at least equivalent to that received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who may otherwise be qualified through job experience to perform various functions including the development, reassessment and modification the HACCP plans and  record review required by 21 CFR 123.8(a)(3). Your firm’s monitoring, corrective action, or verification record review was not done by an individual who had successfully completed training in the application of HACCP principles or was otherwise qualified through job experience to perform these functions. Specifically, your firm HACCP record review was being conducted by (b)(4) employees who have not received appropriate seafood HACCP training. 
 
We have reviewed your response dated October 14, 2015. Although your response commits to providing HACCP training to your HACCP Processing Manager; you have not provided evidence of the completion of this training. Additionally, the Managers of this facility have previously committed to provide the required training to appropriate staff during a regulatory meeting held with the Dallas District Office of the FDA on November 14, 2014; and they have failed to fulfill this commitment. Correction to this observation will have to be verified through future inspection.
 
In addition, 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). Our inspection found several deviations from the current good manufacturing practice requirements in 21 CFR Part 110. We have reviewed your written response to the FDA 483, Inspectional Observations, dated October 14, 2015 and have determined it is inadequate. Although you verbally state you have made changes to your sanitation practices; you did not provide any evidence any of these changes were implemented.
 
Further, your HACCP plans list verification procedures that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
 
a.    Your HACCP plan dated July 6, 2015 for histamine forming fish includes a critical limit at the Receiving CCP for the presence of adequate ice; however, the verification procedures do not require the periodic verification of the internal temperature of the fish received from your suppliers.
 
b.    Your HACCP plan dated July 6, 2015 for histamine forming fish includes a critical limit at the Storage CCP for the presence of adequate ice; however, the verification procedures do not require the periodic verification of the internal temperature of the fish in storage.
 
We have reviewed your response dated October 14, 2015 and determined it is inadequate. Although you have stated your firm is now periodically verifying the internal temperature of product received on ice; this is not reflected in the unsigned HACCP plan dated September 22, 2015 that was provided with your response. 
 
Further, your response dated October 14, 2015 states your firm has contacted customers that received pasteurized crabmeat that did not meet your critical limits and asked they return the impacted product. This action is a firm-initiated recall per 21 CFR 7.46.  We request your staff promptly notify our Recall Coordinators with the appropriate recall information. Recall staff can be contacted at via phone or email at 214-253-5221/5222 or ORADALRecalls@fda.hhs.gov.
 
The Food and Drug Administration has a significant history of violations associated with the most responsible personnel at this facility, including prior issued advisory letters and a regulatory meeting with the Dallas District Office. Based on our history with this facility, the findings of the current inspection, and your firm’s inadequate response; we believe a meeting with your firm’s current management is necessary.
 
You should contact this office to arrange a meeting date and time with district compliance personnel to discuss the above deviations and permanent corrective actions to significantly increase your level of compliance. You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking 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. Please ensure you provide your current HACCP plans for your histamine forming fish, pasteurized canned crabmeat, and caviar. 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. 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). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. 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)).
 
For a domestic facility, 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.
 
Please send your reply to the Food and Drug Administration, Attention: Jeff R. Wooley, Compliance Officer, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have questions regarding any issues in this letter, please contact Jeff R. Wooley, Compliance Officer at 214-253-5251.
 
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
Cc:
 
Michael R. Intondi, Manager
Halperns’ Steak and Seafood Company, LLC.
2158 W. Northwest Hwy, Suite 410
Dallas, Texas 75220
 
Lori Woznicki, Food and Drug Inspections Branch Manager
Division of Regulatory Services
Texas Department of State Health Services
1100 E. 49th Street – Mail Code 1987
Austin, Texas 78756

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