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U.S. Department of Health and Human Services

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Enforcement Actions

Blue Marine Seafood Inc 11/27/13

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone:      949-608-2900
FAX:            949-608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                                     
SIGNATURE REQUIRED
 
November 27, 2013                                                                                                         
               WL # 3-14
James C. Ho, President
(Care of)
Davis M. Lee, Acting President
Blue Marine Seafood Inc.
4988 Corona Ave
Vernon, CA, 90058-3212
 
Dear Mr. Ho:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 4988 Corona Ave, Vernon, CA, from October 21 – 29, 2013. 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 (CGMP) 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 fresh raw fish including your tuna, amberjack, mackerel, and salmon 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 current 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
We acknowledge the receipt of your firm’s written response letter on November 12, 2013. The agency has reviewed your response and we continue to have concerns because you have not provided any detailed evidence or documentation of corrections for many of your reported corrections.
 
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 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, your firm’s HACCP plan for fresh raw ready to eat (RTE) salmon does not list the food safety hazard of parasites. Additionally, you do not have assurance from all your suppliers that the salmon has been aquaculture farmed and fed, or otherwise processed, in a manner to control the parasite hazard.
 
Your response states that a new hazard analysis will be performed and a new HACCP plan will be made to address the issue within the month. Your response is inadequate. You have not submitted a new HACCP plan and documentation that you have implemented the plan, and your response does not provide for timely correction.
 
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, your firm’s HACCP plan for fresh raw ready to eat salmon lists critical limits at the receiving and storage critical control points that are not adequate to control the hazard of pathogen growth such as Listeria monocytogenes. Specifically,
 
a)    The critical limits at the receiving step of (b)(4) are not adequate. Additional information regarding controlling pathogen growth through transportation at the receiving step can be found in the current 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (Hazards Guide), Chapter 12, Control Strategy #1.
 
b)    The critical limits at the cooler storage step of (b)(4) are not adequate. Additional information regarding controlling pathogen growth during refrigerated storage can be found in the Hazards Guide, Chapter 12, Control Strategy #2. 
 
Your response states that a new hazard analysis will be performed and a new HACCP plan will be made to address the issue within the month. You have not submitted a new HACCP plan and documentation that you have implemented the plan, and your response does not provide for timely correction.
 
3.    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 procedures for your fresh raw ready to eat salmon and your fresh raw ready to eat scombroid species fish at the receiving critical control point to control pathogen growth in salmon, and histamines and pathogen growth in Scombroid species fish. Specifically,
 
a)    You did not implement the monitoring procedure to visually check for the (b)(4) for salmon you received during the period of September – October of 2013.
 
b)    You did not implement the monitoring procedure to visually check for the (b)(4) for scombroid species fish other than tuna, such as mackerel and amberjack.   For example, you did not fully implement the monitoring procedures for amberjack received from [b, 4] on 9/28/13, nor for yellowtail and mackerel received on 10/18/13 from (b)(4).
 
Your response states that new recordkeeping forms will be made to address the issue. Your response is not adequate. You have not submitted evidence that you are implementing the monitoring procedures, nor have you submitted evidence that the responsible employees have been re-trained on monitoring procedures.
 
4.    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, your corrective action plans at processing and storage CCPs to control pathogen growth in fresh raw ready to eat salmon, and pathogen growth and histamines in fresh raw ready to eat scombroid species, are not appropriate.  Specifically,
 
a)    Your HACCP plan for fresh raw salmon lists corrective action procedures of (b)(4) at the Storage-Cooler CCP. These corrective action procedures do not ensure that the cause of the deviation is corrected.
 
b)    Your HACCP plan for fresh scombroid fish lists corrective action procedures of (b)(4) at the Processing CCP and Storage CCP. These corrective action procedures do not ensure the cause of the deviation is corrected.
 
Your response states that a new hazard analysis will be performed and a new HACCP plan will be made to address the issue within the month. Your response is inadequate. You have not submitted a new HACCP plan and documentation that you have implemented the plan, and your response does not provide for timely correction.
 
5.    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 condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects to food, and the protection of food, food packaging material, and food contact surfaces from adulteration, with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by: 
 
Protection from Adulteration
 
a)      On several occasions, employees were observed using a hose to rinse the processing room floor causing water to splash from the floor onto plastic liners stored underneath the packaging table and onto the descaling head of the electric fish scaler that hung approximately 1 foot above the processing floor. The plastic liners are used to pack RTE fresh fish fillets. The electric fish scaler is used to remove the scales from fresh, raw salmon that intended for raw consumption.
 
b)      An employee was observed using a hose to rinse Styrofoam boxes caused water to splash from the floor onto Styrofoam boxes that were placed on top of a pallet. Finished RTE salmon fillets were stored on these Styrofoam boxes.
 
Prevention of Cross Contamination
 
c)      The tip of a hose was in direct contact with the floor. This hose was used to rinse fresh fish intended for raw consumption and to rinse the cutting boards used to process fresh fish intended for raw consumption.
 
d)     Strip curtains that contact employees’ outer garments and hands as they enter the processing room were observed with encrusted residue and a pinkish apparent fungal growth on them.
 
e)      A spray bottle of sanitizer and a bottle of bleach that had been placed directly on the warehouse floor were later observed placed on a cutting board that had been cleaned and sanitized.
 
Condition and Cleanliness of Food Contact Surfaces
 
f)       The revolving head of the handheld electric fish scaler was observed with black and yellow residue and fish scales after it was cleaned, sanitized and reportedly ready for use. The electric fish scaler is used to remove the scales from fresh, raw salmon intended for raw consumption.
 
g)      Cutting boards used to fillet RTE raw salmon had numerous scratches and grooves with apparent food debris in them.
 
h)      Food contact surfaces including cutting boards, filleting knives, and fish scaler were observed being rinsed with water and sanitized with 200ppm bleach solution without first being cleaned with detergent.
 
Your response includes records of re-training the responsible employee, revised cleaning and sanitation procedures, and photographs of wall mounts installed for the hose and fish scaler. Your response is inadequate. Your response does not include evidence of corrections for many of the items. For example, you did not include evidence: that the fish scaler was re-cleaned; that the strip curtains have been cleaned; that you have repaired or replaced the worn and damaged cutting boards; or that you have and are now using detergent during cleaning and sanitation activities.
 
(b)(3)
 
The above violations are not intended to be an all-inclusive list of violations in your plant. 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), and (b)(3). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the seafood HAACP regulation. 
 
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
Blake Bevill, Director
Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 
Foods: 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.
 
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769. 
 
Sincerely,
/S/                                                                                  
Alonza E. Cruse, Director
Los Angeles District
 
Cc:
 
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence