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WARNING LETTER

A.M. Wholesale Fish Co. Inc. dba Syosset Seafood Co. Oct 10, 2014

A.M. Wholesale Fish Co. Inc. dba Syosset Seafood Co. - 10/10/2014


Recipient:
A.M. Wholesale Fish Co. Inc. dba Syosset Seafood Co.


United States

Issuing Office:
Dallas District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

October 10, 2014   
 
2015-DAL-WL-003
 
                                               
WARNING LETTER
                                                                                   
UPS Overnight                                                                   
 
 
Michael R. Intondi, Co-Owner
A.M. Wholesale Fish Co., Inc. dba Syosset Seafood Co.
2158 W. Northwest Hwy, Suite 410
Dallas, Texas 75220
                                                                                               
Dear Mr. Intondi,
 
We inspected your seafood processing facility, located at 2158 W. Northwest Hwy, Suite 410, Dallas, Texas, on January 30, 2014 through February 5, 2014.   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, smoked salmon, 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 to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for canned pasteurized crabmeat lists critical limits at theReceiving critical control point that are not adequate to control pathogen growth and toxin formation, including Clostridium botulinum.
 
Specifically, your Receiving CCP lists critical limits of “Containers of crabmeat are cooled with an adequate quantity of (b)(4) or internal temperature of shipping container was 40°F or below during shipping or time”. 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 can to be less than 40°F throughout transit or all lots received with transportation records showing product was held at less than 40°F throughout transit; or 3) the transit time for the product (including all time outside of a controlled environment) was less than 4 hours and the internal temperature was less than 40°F at receipt.
 
We have reviewed your response dated 02/28/2014 and determined it is inadequate. The HACCP Plan entitled “Pasteurized blue crabmeat” includes monitoring procedures at your Receiving CCP that state “Continuous time and temperature data logger in representative number of containers”. If you indicate a representative number of containers will contain a data logger, you should also indicate how the representative number will be determined. However, we note, it would be appropriate to monitor and maintain records showing the temperature of the truck was maintained at less than 40°F throughout transit if that is the control strategy your firm chooses to implement.
 
In addition, our inspection identified a shipment of canned pasteurized crabmeat for which you were unable to download the data from the time-temperature data logger at the time of receipt and you accepted the shipment. You must ensure you have records to support your critical limits were met at receiving prior to accepting the product. We recommend your critical limit at your Receiving critical control point specifies transportation records show the shipment was maintained at less than 40°F throughout transit.
 
2.    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 Cold Smoked Salmon deviated from your critical limit at the “Refrigerated Storage” CCP of your HACCP plan entitled “Cold Smoked Salmon” dated 12/10/2013 and unrevised since 11/23/2011. Your critical limit states “Cooler temperature is 40°F or below”. Your temperature recording chart for 07/31/2013 shows the temperature for cooler (b)(4) exceeded 40°F for approximately 3 hours. The temperature chart also shows on 07/13/2013 cooler (b)(4) exceeded 40°F for approximately 3 hours. Your firm did not take any corrective actions for these critical limit deviations.
 
We have reviewed your written response to the FDA 483, Inspectional Observations, dated 02/28/2014 and have determined it is inadequate. Although you state you are installing a cooler alarm that will notify staff of temperature excursions, your response does not address how you will ensure appropriate corrective actions are taken and documented. Further, you did not provide any evidence corrective actions have been taken on the specific incidents identified above.
 
3.    You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4).
 
a.    Your firm did not follow the monitoring procedure of “Continuous time and temperature data logger in representative number of containers” at your Receiving critical control point to control Clostridium botulinum toxin or pathogen growth in your pasteurized canned crabmeat. Specifically, you are not implementing these monitoring procedures for pasteurized canned crabmeat, which are not received with (b)(4). For example, the following shipments were accepted without monitoring the adequacy of the temperature of the truck throughout transit.
 
i.    Shipment of (b)(4) cases of pasteurized canned crabmeat on 1/10/2014;
ii.    Shipment of (b)(4) cases of canned pasteurized crabmeat on 1/14/2014; and
iii.    Shipment of (b)(4) cases of canned pasteurized crabmeat on 1/17/2014
iv.    Shipment of (b)(4) cases of canned pasteurized crabmeat on 1/28/2014.
 
In addition, our inspection found your firm is accepting fish and fishery products based on the time in transit being less than (b)(4) hours; however, the shipping records do not contain the loading time of the trucks for you to be able to verify the transit time. Further, if you choose to monitor the transit time you should update your HACCP plan to include requirements for records showing transit time was less than (b)(4) hours and the internal temperature of the product at time of delivery was less than 40°F.
 
b.    Your firm did not follow the monitoring procedure of “Continuous with visual checks at (b)(4)” at your “Refrigerated Storage” critical control point to control Clostridium botulinum toxin or pathogen growth, where applicable, as listed in your HACCP plans for canned pasteurized crabmeat, caviar, and cold smoked salmon. Specifically, your firm is not conducting visual checks of your continuous temperature monitoring device on weekends and holidays. In addition, you stated your firm’s visual checks do not include a visual check of the continuous monitoring data.
 
We have reviewed your written response to the FDA 483, Inspectional Observations, dated February 28, 2014 and have determined it is inadequate. Although you state you will no longer accept canned pasteurized crabmeat without a TTR and provided an updated HACCP plan, you did not provide evidence to show the HACCP plan has been implemented and is being adequately monitored. In addition, although you state your firm is now monitoring the continuous temperature monitoring device on weekends and holidays; you did not provide evidence to show the implementation of this practice.
 
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.
 
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). It was observed that your firm did not monitor the safety of water that comes into contact with food or food contact surfaces, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, and maintenance of hand washing, hand sanitizing, and toilet facilities with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
a)    We observed an employee scoop ice off the floor. This ice subsequently comes into direct contact with fresh fishery products.
b)    We observed an employee handling fresh salmon while wearing cotton gloves, which are difficult to clean and maintain in a sanitary condition, which according to management are not cleaned between uses.
c)    We observed standing and pooling water in the fresh fish processing area and employees walking through the water.
d)    We observed two unshielded lights above the fileting and deboning area for fresh fishery products.
 
We have reviewed your written response to the FDA 483, Inspectional Observations, dated February 28, 2014 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.
 
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. 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 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:
 
Gus Pellegrino, Co-Owner
A.M. Wholesale Fish Co., Inc. dba Syosset Seafood Co.
2158 W. Northwest Hwy, Suite 410
Dallas, Texas 75220