• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

The Box Lunch Company, Inc. 1/3/13

  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700

 

UNITED PARCEL SERVICE 
DELIVERY SIGNATURE REQUIRED
 
 
WARNING LETTER
 
 
January 3, 2013
 
Julie DeMasi, President
The Box Lunch Company, Inc.
319 S. Maple Avenue, Suite # 206
South San Francisco, CA 94080
 
Dear Ms. DeMasi:
 
We inspected your seafood processing facility located at 319 S. Maple Avenue, South San Francisco, CA between the following dates:  October 30 and November 9, 2012.  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 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 refrigerated ready-to-eat tuna salad products, including Tuna Salad Sandwiches and Tuna Salad, which are manufactured with scombrotoxin-forming finfish tuna, 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.
 
The deviations listed in this letter are based on the inspection and our review of your firm’s HACCP Plan for your tuna salad products dated November 9, 2012 that you provided to our investigator during the close-out meeting of our inspection.
 
Your significant violations are 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 refrigerated ready-to-eat Tuna Salad products does not list the food safety hazards of:

  • scombrotoxin (histamine) formation as a result of time/temperature abuse; and
  • undeclared allergens. FDA has identified allergens as a food safety hazard and must be included in your HACCP plans.   
 
Please refer to Chapter 7 (Scrombrotoxin (Histamine) Formation) and Chapter 19 (Undeclared Major Food Allergens) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Fish Guide) for guidance in determining the appropriate controls for your processing operations.
 
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 Tuna Salad products does not list the critical control points of:  
 
a.    “In-Process Product Storage” to control pathogen growth and toxin formation when your in-process tuna is held (b)(4) (i.e., prior to the start of the sandwich manufacturing operation); and
b.    “Finished Product Storage” for controlling pathogen growth and toxin formation during finished product storage.
 
Please refer to Chapter 12 of the Fish Guide for additional information related to Pathogenic Bacteria and Toxin Formation as a Result of Time and Temperature Abuse for appropriate control strategies for your process.
 
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. 
 
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.
 
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 copies of any revised HACCP plans, at least five (5) product days worth of HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, and 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 attention:
 
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
 
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
                                                                                    
Sincerely,
/S/ 
Barbara J. Cassens
San Francisco District Director       
 
cc:  
John K. Jacob, General Manager/Director of Operations
The Box Lunch Company, Inc.
319 S. Maple Avenue, Suite # 206
South San Francisco, CA 94080