Inspections, Compliance, Enforcement, and Criminal Investigations

SI Marketing Inc. 4/4/17

 

  

Black HHS-Blue FDA Logo

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700 

 
 

 

UPS OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
WARNING LETTER
 
April 4, 2017
 
Peter D.J. Kim, President
SI Marketing Inc., dba Coco’s Fish Market
905 Keeaumoku Street, Suite 102
Honolulu, Hawaii 96814                   
                                               
Dear Mr. Kim:
 
We inspected your seafood processing facility located at 905 Keeaumoku, Suite 102, Honolulu, Hawaii, between the following dates: February 6 and February 13, 2017. 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 fresh, refrigerated seafood products, including your histamine-forming fish, tuna, 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.
 
The deviations listed in this letter are based on observations we made during the inspection and our review of your HACCP plan for refrigerated, fresh histamine-forming fish (i.e.: tuna) intended for raw consumption, entitled “HACCP PLAN FOR FRESH TUNA”, dated September 24, 2016.
 
Your significant violations are as follows: 
 
1.    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 and frequency for “(b)(4)” using a “(b)(4)” at your “Cold storage” critical control point to control pathogenic bacteria growth and toxin formation as listed in your HACCP PLAN for fresh tuna intended for raw consumption. Specifically, our investigators observed that since December 2016, you are currently not (b)(4) monitoring of your cooler temperature.  
 
2.    You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However:
 
a.  your firm did not record monitoring observations of “(b)(4)” by “(b)(4)” at your “Receiving” critical control point to control scombrotoxin formation as listed in your HACCP PLAN for Fresh Tuna, intended for raw consumption. Specifically, our inspection found that on February 2 and 6, 2017, your firm received shipments of scombroid finfish, Ahi Tuna, and failed to have receiving records documenting the (b)(4) to ensure your critical limit of “(b)(4)” has been met. 
 
b.  your firm did not record monitoring observations of “(b)(4)” by “(b)(4)” at your Cold Storage critical control point to control pathogenic bacteria growth and toxin formation as listed in your HACCP plan for Fresh Tuna, intended for raw consumption. Specifically, our inspection found that you are not maintaining a “(b)(4)” to ensure your critical limit of “(b)(4)” has been met. We note that your Daily Sanitation Inspection Check List indicates a (b)(4) for the Refrigerator temperature. However, our inspection found that you currently are (b)(4), and this does not represent the record of your (b)(4) as required by your HACCP plan. Additionally, indicating a pass or fail is not adequate; we recommend that you record the actual temperature measured at the time the monitoring was performed.
 
3.    Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b).  However:
 
a.  your corrective action plan for “Fresh Tuna” to control scombrotoxin (histamine) formation at the “Receiving” critical control point is not appropriate. Specifically, stating “(b)(4)” does not ensure that unsafe product will not reach consumers, and this corrective action plan does not resolve how the cause of the deviation will be corrected.     
 
FDA recommends that you take the following corrective action to a product involved in a critical limit deviation: Chill and hold the affected lot until histamine analysis is performed OR Reject the lot. AND to regain control over the operation after a critical limit deviation: Discontinue use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved. 
 
b.  your corrective action plan for “Fresh Tuna” to control pathogenic bacteria growth and toxin formation at the “Cold storage” critical control point is not appropriate. Specifically, the first step in your corrective action plan of “(b)(4)” does not prevent further deterioration of the product. 
 
FDA recommends that you add ice to the product, OR move the affected product in the malfunctioning cooler to another functioning cooler, OR freeze the product.
 
Please refer to Chapter 7 (Scombrotoxin (Histamine) Formation) and Chapter 12 (Pathogenic Bacteria and Toxin Formation as a Result of Time/Temperature Abuse) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Hazards Guide), for additional information and guidance on appropriate control strategies for your operations.  
 
4.    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 the following specific areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
a.  Condition and cleanliness of food contact surfaces [21 CFR 123.11(b)(2)]
 
i.  On February 6, 9, and 10, 2017, our investigators observed un-processed Ahi tuna stored directly on the grimy floor of your firm’s walk-in cooler.  
ii.  On February 6, 7, 9, and 10, 2017, our investigators observed your firm transporting un-processed Ahi tuna directly on a dirty cart with build-up of debris.
iii.  On February 6, 7, and 9, 2017, our investigators observed your firm moving raw un-processed Ahi tuna directly with filthy gaffs which were covered with hardened debris.
 
b.  Maintenance of hand washing, hand sanitizing, and toilet facilities [21 CFR 123.11(b)(4)]
 
On February 9, 2017, our investigators observed your restroom lacked toilet paper and hand soap for employees to use.
 
c.  Proper labeling, storage, and use of toxic compounds [21 CFR 123.11(b)(6)
 
Our investigators observed a can of aerosol insecticide stored on an open shelf of a metal rack near the packaging table of your processing room.
 
d.  Exclusion of pests from the food plant [21 CFR 123.11(b)(8)] 
 
i.  On February 6, 2017, our investigators observed an accumulation of dead flying insects in your facility, including on sticky traps and laying on a table in your storage area and a packing table, shelves and the floor in the processing area.
ii.  On February 6, 2017, our investigators observed a live cockroach on butcher paper used to pack finished product.
 
5.    You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c).  However, your firm did not maintain sanitation monitoring records for the safety of water that comes in contact with food and 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, as required for the processing of fresh tuna intended for raw consumption. Specifically, your “Daily Sanitation Inspection Check List” and “Daily Sanitation Inspecion (sic) Fish Log” records do not contain documentation of the aforementioned areas of sanitation.  Additionally, our inspection found that your firm did not maintain sanitation monitoring for all eight key areas of sanitation on February 2, 2017 as evidenced by the lack of documentation on your designated form in use for that 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.
 
This letter may not list all the violations at your facility. You are responsible for ensuring you operate in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR 110) and food labeling regulation (21 CR 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
We also offer the following comments: 
 
1)  We note that bacterial pathogens is not identified as a significant hazard at your “Receiving” step in your Fresh Tuna HACCP Plan. However, pathogen growth and toxin formation is likely to occur in the event of time and temperature abuse prior to your receipt as a secondary processor. Your Ahi Tuna fish in intended to be consumed without further cooking. As such, its HACCP plan needs to identify pathogen growth as a result of time and temperature abuse as a significant hazard in addition to histamine formation at your “Receiving” critical control point.  
 
2)  We note that histamine formation is not identified as a significant hazard at your “Cold storage” step in your Fresh Tuna HACCP Plan. However, scombrotoxin (histamine) formation, as well as pathogen growth, is likely to occur in this histamine-forming fish in the event of time and temperature abuse during cold storage. As such, its HACCP plan needs to identify histamine formation as a result of time and temperature abuse as a significant hazard in addition to pathogens at your “Cold storage” critical control point.  
 
3)  Your corrective action plan for “Fresh Tuna” to control “allegan” (sic) at the “Processing Cleaning, cutting, and packing” critical control point is not appropriate. Specifically, stating to “(b)(4)” does not ensure that unsafe product from undeclared allergens will not reach consumers. 
 
4)  (b)(3)(A) 
 
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover 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.
 
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 your HACCP plan 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.
 
Please send your reply to the attention:
 
Lawton W. Lum      
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
 
Please reference the CMS case # 521356 in your response.
 
If you have any questions about the content of this letter please contact Juliane Jung-Lau, Compliance Officer, at (510) 337-6793.
 
Sincerely,
/S/ 
Darla R. Bracy                                                                                                                                 
Acting District Director
San Francisco District
 

 

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