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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Topway Enterprises, Inc 3/15/12

  

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 

 

WARNING LETTER
 
 
March 15, 2012
 
2012-DAL-WL-16                                                                                                   
 
UPS OVERNIGHT MAIL                                                               
RETURN RECEIPT REQUESTED
 
Jeff Liao, Co-Owner and President
Topway Enterprise, Inc. d.b.a Kazy’s Gourmet
4001 Briarpark Drive
Houston, Texas 77072
                                                                                               
Dear Mr. Liao:
 
We inspected your seafood processing facility, located at 4001 Briarpark Drive, Houston, Texas, on October 17, 2011 to November 4, 2011 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 Vacuum Packed Yellowtail (Hamachi) and Histamine Prone Fish are adulterated, in that they have been 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 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."  
 
Your firm receives Vacuum Packed Yellowtail (Hamachi) with chemical cooling media such as gel packs and Time Temperature Integrators (TTI).Your critical limit does not address assuring the product was maintained at the 38° or below the entire time it was in transit.
 
The 4th addition of the Fish and Fishery Products Hazards and Control Guide states “reduced oxygen packaged products in which refrigeration is the sole barrier to outgrowth of non-proteolytic Clostridium botulinum and the spores have not been destroyed (e.g. vacuum packaged refrigerated raw fish), the temperature should be maintained below 38°F from packing to consumption”.
 
We add this issue can be resolved by changing your CL at receiving for Histamine to 38°F or below.
 
2. 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 Vacuum Packed Yellowtail(Hamachi) lists a monitoring procedure at the receiving critical control point that is not adequate to control histamine formation.
 
Specifically, during the review of your revised Seafood HACCP Plan for Vacuum Packed Yellowtail (Hamachi) at the receiving CCP, it was noted you failed to adequately state how you would perform your monitoring practice.   
 
Since your firm uses gel packs your plan should state “to monitor the quantity and frozen status of cooling media at the time of delivery and the internal temperature of the fish at the time of delivery”, to ensure you are meeting your critical limit for Histamine and Clostridium botulinum
 
3. 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). 
 
a. Your corrective action plan for Vacuum Packed Yellowtail (Hamachi) at the cooler storage critical control point to control Clostridium botulinum is not appropriate. Your corrective action plan states “if TTI color changes to (b)(4) or (b)(4) reject”. 
 
Your corrective action plan states “if cooler temperature is ≥ (b)(4)°F for (b)(4) hours, check internal temperature, if internal temperature is (b)(4), destroy and TTI color changes to (b)(4) or (b)(4) reject”.  The corrective actions do not address corrective action to be taken to regain control over the operation after a critical limit deviation.
 
b. Your firm’s seafood HACCP plan dated March 25, 2011, for Fresh Tuna list a corrective action plan at the receiving CCP that states to “re-ice, if ice is not adequate; check internal temperature. If temperature is equal to or greater than (b)(4), reject”. Your firm’s corrective action plan does not address discontinuing the use of a supplier or carrier until evidence is obtained that transportation practices have improved.
 
c. Your firm’s seafood HACCP plan dated March 25, 2011, for Fresh Tuna list a corrective action plan at the storage CCP that states to “if cooler temperature is (b)(4) for (b)(4) hours, re-ice then check internal temperature. If internal temperature is (b)(4), destroy”. Your firm’s corrective action plan does not address to indentify what corrective action you will take to regain control over your operation after a critical limit deviation and how you would modify your process to avoid a reoccurrence
 
We received a response dated November 21, 2011, in which your Assistant Manager stated you had revised your HACCP Plans to correct the deviations noted in the FDA 483. A revised HACCP plan for Vacuum Packed Yellowtail dated November 11, 2011, was provided. Your firm’s response is inadequate because of the deviations noted above and no documentation was provided that your firm implemented the changes made. Evidence such as copies of your fresh seafood receiving logs, thermometer calibration records and temperature charts were not provided.
 
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 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) 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.
  
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). FDA will assess and collect fees for reinspection-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 reinspection-related costs.
   
Please send your reply to the Food and Drug Administration, Attention: Ronda Loyd-Jones, Compliance at 4040 North Central Expressway, Suite 300, Dallas, Texas 75204.  If you have questions regarding any issues in this letter, please contact: Ronda Loyd-Jonesat 214-253-5242.
 
Sincerely,
/S/ 
Reynaldo Rodriguez Jr.
Dallas District Director
 
Cc:    
Akemi Kurokawa, Co-Owner
(b)(4)