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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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All American Trading Of Houston 11/19/12

  

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 

 

November 19, 2012
 
2013-DAL-WL-017
 
WARNING LETTER
 
 
UPS OVERNIGHT
 
Andreas J. Marcopoulous, President
All American Trading of Houston, Inc.
6622 Supply Row
Houston, TX 77011
                                                                                               
Dear Mr. Marcopoulous:
 
We inspected your seafood distribution establishment, located at 6622 Supply Row, Houston, Texas,on September 6 through 10, 2012.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 refrigerated herring marinades and sauces, caviar, and cod roe 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.
 
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 capelin caviar to control the food safety hazard of pathogen growth and toxin formation, including C. botulinum.
 
We acknowledge receipt of your September 24, 2012, letter in response to the FDA 483. However, your response does not address this observation.
 
  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 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, further review of your firm’s HACCP plan for herring and cod roe does not list the food safety hazard of pathogen growth and toxin formation, including C. botulinum.
 
  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 herring and cod roe lists a critical limit at the receiving critical control point (CCP) that is not adequate to control pathogen growth and toxin formation, including C. botulinum. Specifically, your plan’s critical limit of, “Temperature Check Must be under (b)(4)” does not ensure that refrigerated fishery products have been held at or below an ambient or internal temperature of 40°F throughout transit.
 
We acknowledge receipt of your September 24, 2012, letter in response to the FDA 483. However, your response does not address this observation.
 
  1. 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 herring and cod roe does not list a monitoring frequency at the receiving CCP, and lists a monitoring procedure at the storage CCP that is not adequate to control pathogen growth and toxin formation, including C. botulinum.
 
Specifically, further review of your plan reveals that:
    1. Your plan fails to list a temperature monitoring frequency at the receiving CCP. FDA recommends that every shipment be monitored. Further, we recommend that a representative sample of a minimum of twelve containers selected from throughout every shipment be measured, unless there are fewer than twelve containers in the lot, in which case all containers should be measured.
    2. Your plan lists a monitoring method of manually checking the storage temperature (b)(4). However, for storage of refrigerated product, FDA recommends the use of a continuous temperature recording device with a visual check of the recorded data at least once per day.
 
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.
 
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 documentation with your response, such as HACCP and importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 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 for your fish or fishery products, including those 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)).
 
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: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214) 253-5335.
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director