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WARNING LETTER

Los Angeles Fish Co. 07/03/2016

Los Angeles Fish Co. - 03/07/2016


Recipient:
Los Angeles Fish Co.


United States

Issuing Office:
Los Angeles District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax            (949) 608-4415

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                            
 
March 7, 2016
WL# 22-16
Mr. Hisato Doizaki, General Manager
Los Angeles Fish Co.
420 Stanford Ave
Los Angeles, CA  90013-2121
                                                                                                                                               
Dear Mr. Doizaki:
 
We inspected your seafood processing and importer establishment, located at 420 Stanford Avenue, Los Angeles, California on November 18, 20 and 23, 2015. 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), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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).   
 
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4). 
 
Accordingly, your tuna, salmon and fish products you import 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.
 
We did not receive a response to the FDA483 issued to you on November 23, 2015.
 
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 salmon intended for raw consumption to control the food safety hazards of:
 
a.  Parasites
b.  Pathogen growth and toxin formation
c.  Undeclared allergens (fish species)
 
Please refer to Chapter 5, 12, and 19 of the Fish and Fishery Products Hazards and Controls Guidance for guidance on determining appropriate critical limits, monitoring procedures and critical control points to control the hazards of parasites, pathogen growth and undeclared allergens.  
 
2.    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,
 
a.  your firm’s HACCP plan for “Fresh Scombroid Fish Products” lists a critical limit of (b)(4) at the receiving critical control point that is not adequate to control the hazard of “scombrotoxin” (histamine) formation.
 
b.  your firm’s HACCP plan for “Fresh Filleting Scombroid Fish Products” lists a critical limit of (b)(4) at the receiving critical control point that is not adequate to control the hazard of “scombrotoxin” (histamine) formation.
 
A temperature of 45°F is not appropriate to control the hazard of histamine. Your critical limits at the receiving critical control point list multiple control strategies including (b)(4) which require different monitoring procedures. Your plan should clearly distinguish which monitoring and verification procedures apply to which critical limits. For example, a more appropriate critical limit for fish delivered under chemical cooling media such as gel packs, is an adequate quantity of frozen gel packs to maintain the product at 40°F or less throughout transit AND internal temperatures of all fish at delivery are 40°F or below. 
 
c.  your firm’s HACCP plans for “Fresh Scombroid Fish Products” and “Fresh Filleting Scombroid Fish Products” list a critical limit of (b)(4) at the cooler storage critical control point that is not adequate to control the hazard of “scombrotoxin” (histamine) formation.
 
Please refer to Chapter 7 of the Fish and Fishery Products Hazards and Controls Guidance for guidance on determining appropriate critical limits and corresponding monitoring procedures to control the food safety hazard of scombrotoxin (histamine) at the receiving and cooler storage critical control points.
 
3.    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,
 
a.  your firm’s HACCP plan for “Fresh Scombroid Fish Products” and “Fresh Filleting Scombroid Fish Products” list a cooler temperature monitoring frequency of “Twice daily on normal working hours (Mon-Fri)” at the “cooler storage” critical control point that is not adequate to control the hazard of “scombrotoxin formation”. 
 
For refrigerated storage, FDA recommends the use of equipment, on site, capable of continuously monitoring and recording temperatures on a 24 hour a day/7 day a week basis, with a daily check of the record and a daily check of the equipment. A monitoring frequency of 2 times a day does not provide an equivalent assurance of safety and does not account for storage of product overnight or during non-operational days (i.e. Holiday’s and weekends).   Please refer to Chapter 7 of the Fish and Fishery Products Hazards and Controls Guidance for guidance on determining appropriate critical limits and monitoring procedures to control the food safety hazard of scombrotoxin (histamine) formation during cooler storage.
 
b.  your firm’s HACCP plan for “Fresh Scombroid Fish Products” and “Fresh Filleting Scombroid Fish Products” lists a monitoring frequency at the receiving critical control point that is not adequate to control the hazard of scombrotoxin (histamine) formation. Specifically, your plan lists a monitoring frequency of “random sampling of fish”. Your firm is checking the internal temperature of (b)(4). This monitoring frequency is not adequate because it is not representative of the lot.   Please refer to Chapter 7 of the Fish and Fishery Products Hazards and Controls Guidance for guidance on determining an appropriate monitoring frequency. 
 
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 frequency of checking (b)(4) at the receiving critical control point to control “scombrotoxin formation” listed in your HACCP plan for “Fresh Scombroid Fish Products” and “Fresh Filleting Scombroid Fish Products”. Specifically, your firm is checking the adequacy of ice of (b)(4).
 
5.    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 Scombroid Fish Products” at the receiving critical control point to control the hazard of “scombrotoxin formation” is “Reject and Return”. This corrective action does not include how you will correct the cause of the deviation. 
 
b.  your corrective action plan for “Fresh Filleting Scombroid Fish Products” at the receiving critical control point to control the hazard of “scombrotoxin formation” is (b)(4).This corrective action does not include how you will correct the cause of the deviation. 
 
6.    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 prevention of cross-contamination from insanitary objects and protection of food, food packaging material, and food contact surfaces with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the following observed on November 18, 2015:
 
a.  Prevention of cross-contamination from insanitary objects:
i.  An employee was observed picking up a piece of trash from the processing room floor with his gloved hand and then exiting the processing room floor to discard the trash. The employee returned to the processing room and continued to handle and fillet fresh salmon without washing or sanitizing his hands or changing gloves.
 
ii.  On several occasions an employee was observed touching the soiled processing room door when entering and exiting the processing room. The employee returned to the processing room and continued to handle and fillet fresh salmon without washing or sanitizing his hands or changing gloves. 
 
b.  Protection of food, food packaging material, and food contact surfaces from adulteration:
i.  Rust was observed on the ceiling of your walk-in cooler directly above where exposed tuna loins were being held.
 
7.    You must have and implement written verification procedures, to include product specifications and affirmative steps, for ensuring that the fish and fishery products you import into the United States were processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2). However, your firm has no written verification procedures or product specifications, and did not implement an affirmative step for fishery products imported from (b)(4) including but not limited to (b)(4). Although your firm maintains a HACCP plan from (b)(4) on file, in order to meet the requirements of the affirmative step under 123.12(a)(2)(ii)(D), you must also have a written guarantee from your foreign processor that the imported fish or fishery product is processed in accordance with the requirements of the seafood HACCP regulation, 21 CFR Part 123. You are also required to have written verification procedures that include product specifications. In addition, we noted that the referenced HACCP plan was from 2010; the foreign manufacturer’s HACCP plan and the written letter of guarantee should be updated on an annual basis.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination". We may also seize your product(s) and/or enjoin your firm from further violating the Act.
 
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 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.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
CAPT Daniel Cline, Acting Director
Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
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)). For a domestic facility, 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.
 
Additional Comments:
On November 18, 2015, there were (b)(4) tuna loins stored with no ice on a cart in your walk-in cooler. The internal temperature of the tuna loins were measured by the FDA Investigator using a calibrated thermometer and four loins were found to be above 40°F (41.5F°F, 41.6°F, 41.5°F, and 41.3°F). However, the temperature of the cooler was found to be below 40°F.  Your firm’s representative explained that these tuna loins may have been previously stored in your display room for walk-in customers. You should re-evaluate your process for storing tuna and other fishery products outside of your cooler and determine whether a critical control point(s) to control the hazard of histamine formation and pathogen growth and toxin formation is needed. 
 
If you have questions regarding this letter, please contact Marco Esteves, Compliance Officer, at 949-608-4439.
 
Sincerely,
/S/ 
LCDR Steven Porter, Acting Director
Los Angeles District
 
Cc:      
Mr. Anthony Cigliano, President
Los Angeles Fish Co.
18531 S Broadwick St
Rancho Dominguez, CA 90220-6440
 
 
David M. Mazzera, Chief
Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413
Attn: FDA Correspondence