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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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DJ Tuna Express Inc. 9/29/11

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770 

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
 
WARNING LETTER
FLA-11-44
September 29, 2011
 
 
Diego J. Garcia
President
DJ Tuna Express, Inc.
2265 W 9th Avenue, Bay 3 & 4
Hialeah, FL 33010
 
Dear Mr. Garcia:
 
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located in Hialeah, FL, from August 29, 2011 through September 1, 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 ready-to-eat (RTE) fresh tuna, salmon, and cobia 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 fresh cobia to control the food safety hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.  
 
2.      You must 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(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, your firm’s HACCP plan for fresh tuna entitled “Fresh Fish with the potential Hazard of Scombrotoxin” does not list the food safety hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.
 
3.      You must have a HACCP plan that, at a minimum, lists the critical control points (CCPs), to comply with 21 CFR 123.6(c)(2). A CCP is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However,
 
a.  Your firm’s HACCP plan for fresh salmon entitled “Fresh Aquaculture Salmon from primary Processor” does not list the CCP of storage for controlling the food safety hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.
 
b.  Your firm’s HACCP plan for fresh tuna entitled “Fresh Fish with the potential Hazard of Scombrotoxin” does not list the CCP of in-process storage for controlling the hazards of Scombrotoxin (Histamine) formation and pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.
 
4.      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). However, your firm did not follow the monitoring procedure of the “twice a day” visual examination of the presence of ice at the finished product storage CCP to control histamine formation listed in your HACCP plan for fresh tuna entitled “Fresh Fish with the potential Hazard of Scombrotoxin”. Our investigator noted there was no monitoring record for August 27-28, 2011 for fresh tuna received on August 27, 2011. Our investigator observed the processing of this tuna on August 29, 2011.  
 
5.      You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each CCP, to comply with 21 CFR 123.6(c)(4). However,
 
a.  Your firm’s HACCP plan for fresh salmon entitled “Fresh Aquaculture Salmon from primary Processor” lists a monitoring procedure/frequency at the receiving CCP that is not adequate to control “decomposition bacterial growth”. The “Visual Examination” of “Every Lot Received” of the “Amount of Ice at the time of Receiving” does not constitute a representative number of containers (e.g., cartons and totes) from throughout the shipment at delivery.
 
b.  Your firm’s HACCP plan for fresh tuna entitled “Fresh Fish with the potential Hazard of Scombrotoxin” lists monitoring procedures/ frequencies at the receiving and finished product storage CCPs that are not adequate to control histamine formation. For the receiving CCP, the “Visual Examination” of “Every Lot Received” of “Amount of Ice at the time of Receiving” does not constitute a representative number of containers (e.g., cartons and totes) from throughout the shipment at delivery. For the finished product storage CCP, the “Visual” examination of “Twice a day” of the “Presence of Ice” does not constitute a number of containers (e.g., cartons and totes) from throughout the cooler.
 
6.      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 fresh salmon entitled “Fresh Aquaculture Salmon from primary Processor” at the receiving CCP to control “decomposition bacterial growth” is not appropriate. Your corrective action plan for the critical limit deviation of “Reject Lot” does not address how you will prevent the same or similar deviations to your critical limit of “Internal Temperature 40°F or below” from recurring in the future. Additionally, your alternative corrective action plan for this critical limit deviation of “Re-Ice” fails to address how you will ensure the safety of the affected product following deviations to your critical limit of “Ice completely surrounds product during storage”.
 
b.  Your corrective action plan for fresh tuna entitled “Fresh Fish with the potential Hazard of Scombrotoxin” at the finished product storage CCP to control histamine formation is not appropriate. Your corrective action plan for this critical limit deviation of “Move Product from Malfunctioning Cooler to another Cooler and destroy the products” fails to address the root cause following deviations to your critical limits of “Product Storage at 40 ° F or below Or/and Product held under Ice”.
 
7.      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). However, your firm did not monitor safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the following observations made by our investigator on August 29, 2011:
 
a.  Two employees conducted the cleaning process of food contact equipment and utensils at the end of butchering operations in the processing room using only water from spray hoses. No soap or sanitizing solution was used or applied to equipment or utensils during the process.
 
b.  Two employees carried cut, RTE tuna loins from cutting tables in the processing room to place on racks in the in-process storage area without washing and sanitizing their hands after handling equipment and bringing in raw, whole tuna.
 
c.  Two employees wore absorbent, cloth gloves while handling and butchering whole fish into portions in the processing room.
 
d.  Liquid condensate dripped onto RTE tuna loins that were loosely covered with a sheet of butcher paper in the in-process storage area of walk-in cooler.
 
e.  Rust and loose, flaking paint were on storage rack framing along side and directly over racks containing RTE tuna loins in the in-process storage area of walk-in cooler.
 
f.  The loading bay door in the product packaging and dry storage area was open and unscreened throughout the day.
 
g.  The water hose located in the storage cooler outside of the processing room lacked a backflow prevention device.
 
h.  An accumulation of standing water was in cracks and pitted surfaces on floor throughout the processing room.
 
i.  A fluorescent overhead light fixture was unshielded directly over racks containing cartons of raw fish and empty fish cartons in the walk-in storage cooler.
 
j.  There were no test kits available to measure the strength of sanitizer solution.
 
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.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724.  
                                                                       
Sincerely,
/S/ 
Elizabeth W. Ormond
Acting Director, Florida District