Inspections, Compliance, Enforcement, and Criminal Investigations

Culinary Specialties 3/31/15

  

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
 
March 31, 2015                                                                                                          
WL #13-15
 
Christian Schragner, President
Culinary Specialties, Inc.
1231 Linda Vista Dr.
San Marcos, CA 92078
 
Dear Mr. Schragner:
 
We inspected your seafood processing facility, located at 1231 Linda Vista Dr., San Marcos, CA, from January 10-11, 2015. Additional production and sales records were collected at your facility on March 13, 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, 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 brochettes, canapés, burritos and other appetizers, containing crab, tuna, shrimp, and lobster 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 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 plans do not list the pertinent food safety hazards as follows. 
 
a)    The HACCP Plan "Raw Product, Not Ground" includes Brochettes made with ahi tuna and shrimp. The HACCP plan fails to list the histamine hazard in ahi tuna products, and fails to list the sulfite hazard in shrimp products.
 
b)    The HACCP Plan: "Fully Cooked" includes ready to eat canapés made with smoked salmon, ahi tuna, crab salad, lobster medallions, shrimp, and scallops. The HACCP plans fail to list: the C. botulinum and pathogen growth hazard in smoked salmon and crab products; the histamine and pathogen growth hazard in ahi tuna products; the pathogen growth hazard in lobster medallions and scallop products; and the sulfite and pathogen growth hazard in shrimp products.
 
c)    The HACCP Plan: "Heat Treated Product, Not Ground" includes products such as crab cakes, shrimp and scallop rangoon, coconut shrimp, lobster and shrimp burrito, and shrimp eggrolls. The HACCP plan fails to list the C. botulinum hazard in the crab products, and fails to list the sulfite hazard in the shrimp products.
 
Lastly, the three HACCP plans listed above fail to list the fish, crustacean shellfish, nut, milk, wheat, and egg allergen hazards, as appropriate, for the subject products. 
 
2.    You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point 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 ""Fully Cooked" for ready to eat canapés made with various ingredients such as smoked salmon, seared ahi, crab salad, lobster medallions, and shrimp does not list the critical control points of:
 
i.    Receiving - for controlling the food safety hazard(s) of histamines and pathogen growth in ahi tuna, and C. botulinum in vacuum packed or reduced oxygen packaged smoked salmon and crab products;
 
ii.    Refrigerated storage - to control histamines, pathogen growth and C. botulinum in the subject products; and
 
iii.    Labeling - to control for allergens.
 
b)    Your firm’s HACCP plans for products containing shrimp do not list the critical control point(s) of receiving and/or labeling for controlling the food safety hazard(s) of undeclared sulfites.
 
c)    Your firm’s HACCP plan for “Heat Treated Product, Not Ground” includes crab cakes and does not list the critical control points of:
 
i.    Receiving and refrigerated storage - for controlling the food safety hazard(s) of C. botulinum.
 
ii.    Labeling - to control the allergen hazards.
 

3.    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 sushi roll products including California Rolls, Spicy Tuna Rolls, Salmon Rolls, and Crunchy Crab Rolls, to control the food safety hazards of histamines, pathogen growth / toxin formation, and allergens. You purchase sushi roll products from (b)(4) in (b)(4); you sell and distribute the sushi products to your customers.

 

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 to food, and 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:

 
On February 11, 2015 the following conditions were observed
 
  • The employee performing Pre-Op Sanitation Monitoring touched food contact surfaces of utensils and equipment, including scoops, knives, and shredder blades with his bare hands while checking them for cleanliness. The employee did not wash his hands prior to touching the items; the items are not washed/sanitized again before they are used. 
  • A fixed metal plate located on the floor threshold between kitchens where production personnel and equipment pass had accumulated water/liquids underneath; the water/liquid was expelled from beneath the metal plate when a person stepped on it.
  • The cement thresholds in the front of the storage freezer for finished products, and in the front of the blast chiller, are rough, pitted and not easily cleanable.
  • An unlabeled spray bottle with light amber colored liquid inside was located on the rack near the utensil washing 3-compartment sink.
 

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 into contact with food or food contact surfaces, including water used to manufacture ice; condition and cleanliness of food contact surfaces; and control of employee health conditions, as required for the processing of ready to eat canapés containing seafood.

 
Specifically, your daily sanitation monitoring records “Pre-Operational and Operational Sanitation Check-Off Sheets”, including the records for February 19 - 20, 2015 during seafood production, do not include:
  • Safety of water, including the presence of required backflow prevention devices at hose outlets;
  • Condition and cleanliness of food contact surfaces, including the concentration of chemical sanitizers used on such surfaces; and
  • Control of employee health conditions.
(b)(3)
 
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: 
 
CAPT Dan Cline, Acting Director
Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 
Our review of your three HACCP plans, listed above in item #1, finds that they reference USDA FSIS regulations 9 CFR 417.3(a)(1-4) for corrective actions. Although the USDA regulations referenced in your HACCP plans appear substantially equivalent to the FDA requirements for corrective actions, listed in 21 CFR 123.7, your HACCP plans for fishery products should either contain pre-determined corrective actions plans, or reference the applicable FDA regulations.
 
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:
 
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413

Page Last Updated: 04/10/2015
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