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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Seven Seas Smoke House and Catering Services, Inc. 5/1/13

  

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
 
May 1, 2013                                                                                                                WL# 35-13
 
Yelena Gutenmakher, Owner
Seven Seas Smoke House and Catering Services, Inc.
7325 Greenbush Ave
N. Hollywood, CA, 91605-4004
 
Dear Ms. Gutenmakher:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 7325 Greenbush Ave, N. Hollywood, CA from February 25, 2013 through March 19, 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 smoked vacuum packed fishery products 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 written response letter on April 11, 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:
 
HACCP Violations

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,
 
a.    Your firm’s HACCP plan for ready to eat (RTE) cold smoked vacuum packed salmon, sturgeon, steelhead trout, mackerel and escolar does not list the food safety hazard(s) of histamines (in escolar and mackerel), parasites (in mackerel), and undeclared allergens (all fish species). In addition, you do not have controls in place as follows:
 
  • You lack controls for pathogen growth/toxin formation and histamine formation due to cumulative time temperature exposure at the thawing, brining, drying, cold smoking, and packaging/labeling steps. Furthermore, on 02/25/13 we observed that frozen mackerel had been left in an unrefrigerated processing room to thaw overnight.
  • You lack controls at the receiving, frozen storage, or other step(s) to control the parasite hazard in mackerel.
 
b.    Your firm’s HACCP plan for RTE hot smoked vacuum packed salmon, sturgeon, mackerel, escolar, trout, and paddlefish does not list the food safety hazard(s) of histamines (in escolar and mackerel), parasites (in mackerel), and undeclared allergens (all fish species). In addition, you lack controls for histamine formation due to cumulative time temperature exposure at the thawing, brining, and drying steps. 
 
We have reviewed your response and have determined it to be inadequate. In your response you state that your HACCP plans do not include a CCP for parasite control in mackerel because the products are received frozen. However, you have not provided documented assurance from your supplier that the fish have been frozen in a way that will kill parasites.  Guidance on controlling parasites through freezing can be found in the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, Chapter 5, page 94. 
 
In your response you also provided copies of revised HACCP plans for hot and cold smoked fish products. Your revised HACCP plans now identify the histamine and allergen hazards. The plans include CCPs at thawing and brining to control histamines and at labeling to control allergens. However, you have not provided evidence, such as CCP monitoring records and employee training records, to demonstrate you have implemented the subject HACCP plans. We will verify the implementation during the next inspection of your facility.
 
2.    You must implement the monitoring and verification procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b), (c)(4) and (c)(6). However,
 
a.    For cold smoked mackerel processed on 02/22/2013, 01/16/13 and 08/17/13, hot smoked mackerel processed on 01/23/13 and 10/18/12, and hot smoked whitefish processed on 02/25/13 your firm did not follow the monitoring procedure(s) and frequency of (b)(4) at the Brining critical control point (CCP) to control the Clostridium botulinum hazard listed in your HACCP plans for hot and cold smoked vacuum packed fish. The brining records for the subject dates list (b)(4). However, you are not weighing the fish and you are not determining the actual volume or weight of the prepared brine solution to ensure you meet the (b)(4) brine to fish ratio listed as a critical limit, and you are not measuring the maximum fish thickness. In addition, you have not performed the “Quarterly water phase salt analysis” listed as a verification procedure to ensure a “Minimum water phase salt of 3.5%”, for any of the smoked vacuum packed fish that you have produced in the past year. 
 
b.    For hot smoked fish products, including those processed on 02/27/13, 01/25/13 and 10/22/12, your firm did not implement the monitoring procedure(s) and frequency of (b)(4) at the smoking CCP to control the Clostridium botulinum hazard listed in your HACCP plan for RTE hot smoked vacuum packed salmon, sturgeon, mackerel, escolar, trout, and paddlefish. Production records for the subject lots list (b)(4). In addition, you are not performing the “Annual calibration of the data logger chart recorder” listed as a verification procedure at that step.
 
We have reviewed your response and have determined it to be inadequate as follows:
 
a)    Your response states that you are following the monitoring procedures at the brining CCP and that you are “in the process of finding an appropriate laboratory to perform a Water Phase Salt Analysis”. You did not provide any evidence to demonstrate that you are implementing the monitoring procedures identified at the brining step, and you have not identified when you will begin performing the water phase salt test which is listed in your HACCP plan as a verification step. We will verify the implementation during the next inspection of your facility.
 
b)    Your response states that data logger chart recorders are being calibrated annually. However, you have not provided documentation of that activity.  Your response does not address monitoring (b)(4) during the hot smoking process. 
 
3.    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 ready to eat (RTE) cold smoked vacuum packed salmon, sturgeon, steelhead trout, mackerel and escolar lists a critical limit of (b)(4) at the cooling critical control point (CCP) that is not adequate to control the pathogen hazard.
 
b.    Your firm’s HACCP plan for RTE hot smoked vacuum packed salmon, sturgeon, mackerel, escolar, trout, and paddlefish lists a critical limit of (b)(4) at the cooling CCP that is not adequate to control the pathogen hazard.
 
The HACCP plans included in your response have revised critical limits at the cooling CCPs. The HACCP plan for cold smoked fish products now lists (b)(4). The HACCP plan for hot smoked fish products now lists (b)(4). These revised critical limits are not adequate to control the pathogen growth hazard.
 
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 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; and the proper labeling, storage and use of toxic chemicals; with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:         
 
Condition and Cleanliness of Food Contact Surfaces
 
a.    On 2/27/13, an employee trimming paddlefish was observed wearing metal mesh gloves with a fastening belt that was covered with encrusted food residue. The mesh gloves and the fastening belt were in direct contact with the paddlefish fish and cutting board.
b.    On 02/25/13 an employee was eviscerating whitefish using a brush that was later used to clean a smoked salmon slicer. The brush was not washed and sanitized between these operations.
c.    On 02/25/13 food processing utensils such as knives, scissors, pliers, tongs, fish hooks and a mallet were stored on shelves, hooks and racks or bins with accumulated food residue and debris. Some of the utensils had encrusted food residue on them and some were repaired with tape.
d.    On 02/25-26/13 the smoker carts used to hang and hold fish during the hot and cold smoking process had brown and black residues covering the horizontal and vertical surfaces. Fish are placed upon or otherwise contact many of these surfaces during processing.
 
Prevention of Cross Contamination
 
a.    On 02/25/13 cases of raw chicken were leaking blood/liquids onto other items stored below and onto the floor of cooler #1. Uncovered racks of RTE cold smoked mackerel were also stored in the same cooler in close proximity to the cases of raw leaking chicken.
b.    On 2/25/13, an employee was testing brine with a salinometer that had plastic tape around the bottom. The employee was observed submerging their gloved hand in a brine vat containing mackerel. Another employee was observed submerging his hand and exposed hairy arm into brine while scooping brine from a holding container.
c.    On 02/28/13 a cloth towel was used to wipe down a cutting board and then placed directly on top of in-process RTE smoked mackerel.
 
Protection From Adulteration

a.    On 02/25/13 pooled liquids including fish blood and fish debris were accumulating directly below a smoker cart of in-process whitefish that was staged for smoking. Employees were observed walking back and forth through the pooled liquids and debris. 

Proper Labeling, Storage and Use of Toxic Compounds
 
On 02/25/13 employees used a chlorine based sanitizer at levels >200 ppm on cutting boards and on metal mesh gloves worn during processing.   The items were not rinsed with water following the application of the sanitizer and prior to use. 
 
We acknowledge the reported sanitation corrections, the equipment purchases, and facility repairs contained in your response including replacing a condensing unit, cutting boards, strip curtains, a window in the processing room, and the mesh metal glove. However we find that you response does not fully address our concerns. You have not provided documentation of employee training to prevent reoccurrence of the sanitation/employee practices violations and you have not provided recent sanitation monitoring records as evidence of corrections.
 
General GMP Violations
 
1.    Failure to provide adequate screening or other protection against pests [21 CFR 110.20(b)(7)]. Specifically, the back storage/receiving room door, which opens to the outside, is constructed with metal bars on the top half leaving facility open to the environment outside and providing a potential entry point for pests. 
 
Your response states that you are in the process of repairing the door to ensure closure to the outside and you request an additional six weeks to complete the work. Your response does not provide for timely correction to protect against pest entry to your facility
 
2.    Failure to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures [21 CFR 110.20(a)(1)]. Specifically, during the inspection cardboard boxes, fish vats used for brining, discarded machinery, carts, buckets, lumber, wooden pallets, and overfilled trash cans were observed outside the receiving area. In addition, dozens of apparent animal feces were observed along the side of the facility outside the back storage/receiving room door.
 
Your response states that you are in the process of removing any unnecessary clutter from the areas in the immediate vicinity outside the plant and you refer to photo exhibits included in your response as evidence of corrections. You also state that you donated a full truckload of items to charity.   You further state that on 03/18/13 a pest control company installed exterior bait stations and serviced the interior of the facility.   Your response is not adequate. The photo exhibits you provided are not of the areas described in the observation and you have not provided evidence that you have removed the subject equipment, clutter and waste. 
 
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
 
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
 
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.
 
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