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  5. Blis LLC - 02/04/2016
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WARNING LETTER

Blis LLC


Recipient:
Blis LLC


United States

Issuing Office:
Detroit District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2016-DET-06
 
 
February 4, 2016
 
VIA UPS
 
Mr. Steven R. Stallard, President/CEO
BLiS Caviar, LLC
375 Broadmoor Avenue, SE,  Suite D
Kentwood, MI 49512-3912
 
Dear Mr. Stallard:
 
We inspected your seafood processing facility, located at, 375 Broadmoor Ave SE Ste. D Kentwood, Michigan, on November 5, 2015, through November 17, 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 ready to eat Steelhead Roe, Char Roe, and Brook Trout Roe fishery products 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.
 
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 “Caviar, Roe Steel Head/Trout/Char” does not list the food safety hazard(s) of pathogen growth and toxin formation.
 
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."
 
a.    Your firm’s HACCP plan for ready to eat “Caviar, Roe Steel Head/Trout/Char” does not list the critical control point of receipt of refrigerated roe for controlling the food safety hazard of pathogen growth and toxin formation. Specifically, your firm receives refrigerated roe from (b)(4), and does not list a critical control point in your HACCP plan at receiving to control pathogen growth and toxin formation. FDA recommends establishing a CCP for receipt of caviar delivered refrigerated (not frozen). If product is transported for four hours or less, you may have a critical limit that includes transit time of four hours or less AND the internal temperature does not exceed 40°F at time of delivery. However, if your firm receives refrigerated caviar that has been transported longer than four hours, your firm should establish a critical limit for transportation temperatures (i.e., 40ºF or below) and require that transportation temperatures are monitored and recorded continuously throughout transit. Alternatively, you may opt to establish a critical limit and monitoring procedures for the adequacy of the ice surrounding the caviar at receipt, as well as the internal temperature at time of delivery, or adequacy and condition of cooling media, along with the internal temperature at time of delivery.
 
b.    Your firm’s HACCP plan for ready to eat “Caviar, Roe Steel Head/Trout/Char” does not list the critical control point of refrigerated storage for controlling the food safety hazard of pathogen growth and toxin formation. According to your process flow chart, after receiving the refrigerated product it is then placed in refrigerated cold storage. FDA recommends establishing a CCP for refrigerated storage, with a critical limit of cooler temperature of 40°F or below, and monitoring procedures that continuously measure and record the ambient temperature of the cooler to ensure the product is held at 40ºF or below.
 
We acknowledge your response to the FDA 483, dated 11/24/2015, that included your recently implemented HACCP plan, Hazard Analysis, SOP’s and newly revised labels. We note that your current Hazard Analysis indicates that the pathogen hazard is reasonably likely to occur at both receiving and refrigerated storage; however, you reference the prerequisite programs to control the hazard, “(b)(4)”. Controlling the pathogens by these prerequisite programs, outside of your HACCP plan, is not sufficient. Hazards that are reasonable likely to occur must be controlled by critical control points in your HACCP plan.
 
3.    You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR Part 123.6(c)(3). A critical limit is defined in 21 CFR Part 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."  
 
a.    Your firm’s HACCP plan for ready to eat “Caviar, Roe Steel Head/Trout/Char” lists a critical limit of “product temperature (b)(4) at “(b)(4)” critical control point that is not adequate to control Clostridium botulinum.  Specifically, your current HACCP plan “(b)(4)” CCP indicates product temperature monitoring (b)(4), as a critical limit to control the C. botulinum hazard.
 
When products are packaged in oxygen impermeable materials and/ or are vacuum packaged or packaged under modified atmosphere conditions (i.e., reduced oxygen,) Clostridium botulinum growth and toxin formation is a potential hazard due to the lack of any oxygen transfer in to the packages. Your HACCP plan references refrigerated conditions.
  • When intended to be held under refrigerated conditions, Clostridium botulinum continues as a hazard during all subsequent storage and handling (i.e. following packaging).   FDA recommends a secondary barrier to refrigeration, such as drying, salting, pickling, etc. to control toxin formation. Alternatively, when not controlled via a processing procedure, FDA recommends the use of time/temperature indicators on each package to alert the end user to any time/temperature abuse of each individual package.
  • Alternatively, when intended to be held frozen, FDA recommends labeling on each package to indicate “Keep frozen, thaw under refrigeration immediately before use”, or similar statements to indicate that thawing is to be conducted under refrigerated conditions.
We acknowledge your response dated 11/24/2015 that included your recently implemented HACCP plan, Hazard Analysis, SOP’s, and revised finished product labels for your caviar products. We acknowledge that you updated your labels to include the statement, “Keep Frozen. Thaw Under Refrigeration. Consume Immediately.” However, your current HACCP plan does not include a Labeling CCP, to control Clostridium botulinum at your labeling step.   
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulation and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.   
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking 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.
 
Additionally, 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.
 
Please send your reply to the Food and Drug Administration, Attention: LCDR Kelli Wilkinson, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207.  If you have any questions regarding this letter and /or information related to this case please contact me at (313) 393-8120 or via email at kelli.wilkinson@fda.hhs.gov.  
 
Sincerely,
/S/ 
Art O. Czabaniuk
District Director                     
Detroit District Office