Inspections, Compliance, Enforcement, and Criminal Investigations

L & L CRAB 6/22/15

  

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

Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200-Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
          FAX: (615) 366-7802 

 

June 22, 2015
 
WARNING LETTER NO. 2015-NOL-11
 
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Lee V. Nguyen, Owner
L & L Crab
3811 E. Old Spanish Trail
New Iberia, Louisiana 70560
 
Dear Mr. Nguyen:
                                                                       
During April 15-17, and 29, 2015, a United States Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 3811 E. Old Spanish Trail, New Iberia, Louisiana. This inspection found 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 United States Code (USC) 342(a)(4)]. Accordingly, your frozen vacuum packed crayfish tail meat, fresh crab meat, and frozen vacuum packed crab meat products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby it 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 Internet home page at www.fda.gov.
 
We acknowledge receipt of your firm’s response on May 14, 2015. Our evaluation of your response is discussed below. Violations revealed during the inspection include, but are not limited to:
 
1.     You must conduct, or have conducted for you, a hazard analysis for each kind of fish or fishery product you produce to determine whether there are food safety hazards which are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards which 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 frozen vacuum packed crayfish tail meat to control the food safety hazards of pathogenic survival through cooking, pathogenic bacteria growth and toxin formation as a result of time and temperature abuse, and C. botulinum toxin formation.
 
Your response is inadequate for the following reasons:
 
The HACCP plan provided in your response (for crayfish meat) does not list the critical control points at the (b)(4) steps for controlling the food safety hazard of “Bacterial pathogen growth”.
 
The HACCP plan provided in your response (for crayfish meat) lists critical limits for the “Cook Crayfish” critical control point as: “(b)(4) which fails to include the (b)(4)
 
2.     You must conduct a hazard analysis to determine whether there are food safety hazards which 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 fresh crab meat and for frozen vacuum packed crab meat does not list the critical control points at the (b)(4) step for controlling the food safety hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.
 
Your response is inadequate for the following reasons:
 
The HACCP plan provided in your response (for crab meat) lists critical limits for the critical control points (listed below) which are not adequate to control the hazards (shown below):  
 
-     At the (b)(4) critical control point, the plan provides (b)(4) as the critical limit to be met to control the hazard of “Bacterial pathogen C. botulinum growth”; however, there is no temperature limit included as a critical limit for this critical control point.
 
-     At the (b)(4) critical control point the plan provides (b)(4) as the critical limit to be met to control the hazard of “Bacterial pathogen C. botulinum growth”; however, the time and temperature limits are not specified for this critical control point.
 
-     At the (b)(4) critical control point the plan provides (b)(4) as the critical limit to be met to control the hazard of “Bacterial pathogen C. botulinum growth”; however, the time and temperature limits are not specified for this critical control point.
 
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 which 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 (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 fresh and frozen vacuum packed crab meat does not identify the food safety hazard of environmental chemicals at the “Receiving” step and C. botulinum toxin formation at the (b)(4) step.
 
Your response is inadequate because the HACCP plan for your crab meat does not identify the hazard of environmental chemicals at the (b)(4) step.
 
4.     You must implement the record keeping system listed in your HACCP plan to comply with 21 CFR 123.6 (b) and (c) (7). Your firm did not record monitoring observations listed in your HACCP plan for crab meat, as follows:
 
-        of receiving records at the (b)(4) critical control point to control the “biological pathogen” hazard.
 
-        of the production record at the (b)(4) critical control point to control the “biological pathogens” hazard.
 
-        of the log print out at the (b)(4) critical control point to control the “Pathogen growth and toxin formation” hazard.
 
-        of the production record at the (b)(4) critical control point to control the “Pathogen growth and toxin formation” hazard.
 
-        of the production record at the (b)(4) critical control point to control the “Pathogen growth and toxin formation” hazard.
 
-        of the data logger print out at the (b)(4) critical control point to control the “Pathogen growth and toxin formation” hazard.
 
Your response contained a (b)(4). We will evaluate the adequacy of this response during a review of these logs at a future inspection of your facility.
 
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 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; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and, exclusion of pests as required for the processing of any of the seafood processed at your firm.
 
Your response contained an (b)(4) which lists (b)(4) to be monitored. We will evaluate the adequacy of this response during a review of these monitoring forms at a future inspection of your facility.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
 
You should respond in writing within 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 your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123), and the Current 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.
 
Section 743 of the Act, [21 USC 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 non-compliance 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 USC 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 non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your reply should be directed to the U.S. Food and Drug Administration, Attention:  David Van Houten, Compliance Officer, at the above address. If you have questions, concerning the contents of this letter, you may contact Mr. Van Houten at (615) 366-7813.
 
Sincerely yours,
/s/                                       
Ruth P. Dixon
District Director
New Orleans District

 

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