Inspections, Compliance, Enforcement, and Criminal Investigations

Bestway Sandwiches, Inc. 6/18/15

  

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                                                            
 
June 18, 2015
WL# 22-15
Mr. Khachatur C. Budagyan, CEO/Co-Owner
Bestway Sandwiches, Inc.
1530 1st St
San Fernando, CA 91340-2708
                                                                                                                                               
Dear Mr. Budagyan:
                                                           
We inspected your seafood processing facility, located at 1530 1st St., San Fernando, California on February 24, 27 and March 4, 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. 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 tuna salad and crab pastaproducts are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay 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 March 4, 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 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 “Fully Cooked, Not Shelf Stable Seafood Products (Tuna Salads/Crab Pasta)” does not list the food safety hazards of:
 
a.    Undeclared allergens for your tuna salad and crab pasta products. 
 
b.    Scombrotoxin (histamine) formation for your tuna containing products.  
 
c.    Pathogen growth and toxin formation for your tuna salad and crab pasta.
 
Please refer to Chapter 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 hazard of undeclared allergens. Please refer to Chapter 7 and 12 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 scombrotoxin formation and pathogen growth.
 
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, your firm’s HACCP plan for “Fully Cooked, Not Shelf Stable Seafood Products (Tuna Salads/Crab Pasta)” does not list the critical control points of:
 
a.    Storage of in-process and finished tuna salad products in your cooler for controlling the food safety hazards of pathogenic bacteria growth and toxin formation and scombrotoxin (histamine) formation. 
 
b.    Storage of crab salad in your cooler for controlling the food safety hazards of pathogenic bacteria growth and toxin 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 3 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 and 12 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 pathogenic bacteria growth and toxin formation and scombrotoxin (histamine) formation during cooler storage.
 
c.    Thawing (i.e. under refrigeration) of vacuum packed imitation crab for controlling the food safety hazard of Clostridium botulinum growth and toxin formation.
 
Please refer to Chapter 13 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 Clostridium botulinum toxin formation during thawing.
 
d.    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 “Fully Cooked, Not Shelf Stable Seafood Products (Tuna Salads/Crab Pasta)” lists a critical limit, (b)(4), at your (b)(4) critical control point that is not adequate to control the hazard of “B. Biological (Clostridium Botulism & Clostridium Perfrigens)” listed in your plan.  This critical limit is also not adequate to control the hazards of pathogen growth or scombrotoxin formation.    
 
Evaluating your product’s internal temperature profile and/or cooling times during processing and packaging will help you determine cumulative temperature exposure, and identify appropriate critical control point(s) and critical limit(s). Please refer to the processing and/or cooling control strategies listed in Chapter 7 and 12 of the Fishery Products Hazards and Controls Guidance for guidance on determining appropriate critical control point(s), critical limit(s), and monitoring procedures, for processing your tuna salad and crab pasta products.
 
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.
 
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 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.
 
This letter may not list all the violations at your facility. 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). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
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.
 
If you have questions regarding this letter, please contact Marco Esteves, Compliance Officer, at 949-608-4439.
 
Sincerely,
/S/ 
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:      
Mr. Jack Khandzyan, COO/ Co-Owner
Bestway Sandwiches, Inc.
1530 1st St
San Fernando, CA 91340-2708
 
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

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