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WARNING LETTER

BEK Catering, LLC dba Floppers Foods May 20, 2014

BEK Catering, LLC dba Floppers Foods - 05/20/2014


Recipient:
BEK Catering, LLC dba Floppers Foods


United States

Issuing Office:
New Orleans District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200, Suite 500
Nashville, TN 37217-2565
 
Telephone:  615-366-7801
FAX:  615-366-7802

 

May 20, 2014
 
WARNING LETTER NO. 2014-NOL-14
 
 
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Billy B. Stembridge, Jr., Managing Partner
BEK, LLC dba Floppers Food
19270 Scenic Highway 98                                                                       
Fairhope, Alabama 36532-6825
 
Dear Mr. Stembridge:
 
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 19270 Scenic Highway 98, Fairhope, Alabama, on January 9, 13–15, and 21, 2014. Since you were not manufacturing on the previously mentioned dates, the FDA investigator returned to your facility on February 7, 12-13, 20, 24-25, and March 5, 2014, to observe your manufacturing practices. We found 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), and the Current Good Manufacturing Practice regulation for foods, 21 CFR 110. In accordance with 21 CFR 123.6(g), failure of a 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), 21 USC 324(a)(4)]. Accordingly, your seafood products are adulterated, as 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 on FDA’s Internet home page at www.fda.gov.  A Form FDA 483, Inspectional Observations (FDA 483), listing the deficiencies found, was issued to your firm on January 21, 2014, and again on March 5, 2014.
 
We received your firm’s responses on February 14, 2014, and again on April 1, 2014.  Our evaluations of your responses are discussed below. Violations revealed during the inspections include, but are not limited to:
 
1.    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." Specifically,
 
a.    Your HACCP plan lists a critical limit of cooking Seafood Gumbo at (b)(4) for a minimum of (b)(4) to achieve an internal temperature of (b)(4) for (b)(4) at the critical control point of “(b)(4)” which is not adequate to control the significant hazard of survival of pathogens after cooking.
 
b.    Your HACCP plan lists a critical limit of cooking Shrimp Locksley at (b)(4) for a minimum of (b)(4) to achieve an internal temperature of (b)(4) at the critical control point of “(b)(4);” which is not adequate to control the significant hazard of survival of pathogens after cooking.
 
Your HACCP plan lists a critical limit of cooking Shrimp Locksley at (b)(4) for a minimum of (b)(4) to achieve an internal temperature of (b)(4) at the critical control point of “(b)(4)”  which is not adequate to control the significant hazard of survival of pathogens after cooking.
 
FDA’s Fish & Fisheries Products Hazards and Controls Guidance 4th Edition, Chapter 12, Pathogen Growth & Toxin Formation as a Result of Time and Temperature Abuse, identifies Listeria monocytogenes as the generally selected target pathogen when cooking seafood because it is regarded as the most heat-tolerant, foodborne bacterial pathogen that does not form spores. The selection of L. monocytogenes as the target pathogen requires a 6D process, which means a reduction of six orders of magnitude (six logarithms) in the level of contamination is suitable for safety.  A 6D process requires an internal temperature of 145°F for a minimum of 17 minutes to accomplish a lethal rate. Please provide evidence that after boiling the Shrimp Locksley and/or the Seafood Gumbo for (b)(4) the internal temperature(s) remains equivalent of 145°F for 17 minutes under worst case conditions.
 
c.    Your HACCP plan for Seafood Gumbo lists a critical limit of “(b)(4)” at the critical control point of “(b)(4)” which is not adequate to control of the significant hazard of Clostridium botulinum toxin formation. Your HACCP plan for Seafood Gumbo does not ensure all lots of refrigerated pasteurized crabmeat received are accompanied by transportation records to show the refrigerated pasteurized crabmeat was held at or below 40°F throughout transit. All lots of pasteurized crabmeat should be accompanied by transportation records to show the product was held at or below 40°F throughout transit, or that the product was transported and delivered completely surrounded by ice.
 
We reviewed your response received February 14, 2014. Your response states you have enlisted the help of the (b)(4) for verification and aid in your procedures, monitoring and recording of all critical control points and significant hazards. However, when the FDA investigator inspected your facility on February 7, 12-13, 20, 24-25, and March 5, 2014, your firm did not have all of the critical limits that must be met at each of the critical control points on your HACCP plans.
 
We reviewed your response to the FDA 483 received on April 1, 2014. Your response indicates you have enlisted the help of the (b)(4)  to conduct a cook study and/or provide a method and process of cooking the Gumbo and Shrimp Locksley meets all temperature requirements to ensure the death of pathogens after the cooking process. These responses are inadequate as you have not provided FDA with a copy of your updated HACCP plan. You need to ensure the contents of your HACCP plans list the critical limits that must be met at each of the critical control points, as required by 21 CFR 123.6(c)(3).
 
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 (CCP) 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."  Specifically,
 
a.    Your HACCP plan for Shrimp Locksley does not list the critical control points of cooling, cooler storage, product pouring, and finished product storage for controlling the food safety hazard(s) of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse, as required by 21 CFR 123.6(c)(2).
 
b.    Your HACCP plan for Seafood Gumbo does not list the critical control points of metal inclusion, cooling, cooler storage, product pouring, and finished product storage for controlling the food safety hazard(s) of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse, as required by 21 CFR 123.6(c)(2).
 
FDA’s Fish & Fisheries Products Hazards and Controls Guidance 4th Edition, Chapter 12, Pathogen Growth & Toxin Formation as a Result of Time and Temperature Abuse offers the following strategies to control pathogen growth and toxin formation: transit control; refrigerated storage and refrigerated processing control; and cooling after cooking control.
 
We reviewed your response to the FDA 483 received on February 14, 2014. Your response states “We have modified the (b)(4) of both when the product enters (b)(4) in accordance to the plan. After that the control will move to the (b)(4).” This response is inadequate. Your HACCP plan, not (b)(4) needs to list the critical limits which must be met at each of the critical control points. The (b)(4) log is to document you are following your HACCP plan. Additionally, your response to the FDA 483 received on April 1, 2014 states you will revise your Shrimp Locksley HACCP plan to reflect the pouring and cooling process to ensure the control of bacterial growth hazards. You also state in your response, the Seafood Gumbo “HACCP plan will be amended to (b)(4) ” Please ensure you are in compliance with 21 CFR 123.6(c)(2) which would include listing all critical control points of your operation, such as cooling, cooler storage, product pouring, and finished product storage.
 
3.    You must conduct a hazard analysis for each kind of fish and fishery product 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.” Specifically,
 
a.    Your HACCP plan for Seafood Gumbo does not list the food safety hazard for all allergens at the critical control point of labeling when your firm routinely used  (b)(4) to manufacture the Seafood Gumbo.
 
b.    Your HACCP plan for Shrimp Locksley does not list the food safety hazard for all allergens at the critical control point of labeling when your firm routinely used (b)(4) to manufacture the Shrimp Locksley.
 
We reviewed your response to the FDA 483 received on April 1, 2014. Your response states you will have the finished product containers re-printed to include wheat as an allergen. This response does not address how you will come into compliance with 21 CFR 123.6(c)(1). This regulation requires the food safety hazards that are reasonably likely to occur be listed on your HACCP plans.
 
4.    You must implement the monitoring procedures and frequencies that you have listed in your HACCP plans, as required by 21 CFR 123.6(b). Specifically,
 
a.    Your HACCP plan for Shrimp Locksley states at the critical control point of “(b)(4)” you would monitor the significant hazard of “(b)(4) for every package (b)(4) step. You have no monitoring records for this significant hazard.
 
b.    Your HACCP plan for Seafood Gumbo states at the critical control point of “(b)(4)” you would monitor the significant hazard of “(b)(4)” for every package (b)(4) step. You have no monitoring records for this significant hazard. 
 
c.    Your firm does not have any cooking logs to document monitoring of any significant hazards listed on your Shrimp Locksley HACCP plan and your Seafood Gumbo HACCP plan for operations conducted in September and October 2013.
 
We reviewed your response to the FDA 483 received on February 14, 2014. Your response states you have created a log sheet to document when you verify the packaging containers to ensure the containers show all pertinent information as required, specifically allergens and sulfites. However, when our investigator inspected your facility on February 7, 12-13, 20, 24-25, and March 5, 2014, he found you used (b)(4) to process these products, and (b)(4) was not listed as an ingredient on the finished product containers.
 
You also state you have created and are using a log sheet to record cooking times and temperatures before and after the CCP. Your response states you will record the start time, time at (b)(4), time the CCP starts, the time the CCP ends, and the finish time. However, the record you provided to our investigator during the inspection of your facility on February 7, 12-13, 20, 24-25, and March 5, 2014, indicates while manufacturing Mama’s Gumbo on February 12, 2014, the product reached (b)(4) and started the CCP at (b)(4) This timeframe does not match what is listed on your HACCP plan. Your HACCP plan states you would cook the product at (b)(4) for a minimum of (b)(4) to achieve an internal temperature of (b)(4) Your cooking times need to match an adequate HACCP plan to ensure product safety.
 
We reviewed your response to the FDA 483 received on April 1, 2014. Your response states you are no longer using (b)(4).  Your response also indicates you have records of the (b)(4) received that are insured to be free of (b)(4) as laid out in the HACCP plan of the (b)(4) processor. This response appears adequate and will be verified during our next inspection. 
 
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 condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; proper labeling, storage and use of toxic compounds; control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and exclusion of pests from the food plant, required for the processing of Shrimp Locksley and Seafood Gumbo minimally from November 2013 to March 2014, and/or sanitation corrections records for all of the areas mentioned above. The inspection revealed your firm had sanitation monitoring records for the cleaning of the manufacturing equipment and a local water bill. Your firm did not have sanitation monitoring records for day to day operations, as required by 21 CFR 123.11(c).
 
We reviewed your response to the FDA 483 received on February 14, 2014. Your response states you will follow the eight laws of sanitation. You explained you had several laws of sanitation logged, but were missing some as required. Your response states you have modified the document to reflect all laws of sanitation are captured. However, when our investigator inspected your facility on February 7, 12-13, 20, 24-25, and March 5, 2014, he found your records did not document monitoring for the condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; proper labeling, storage and use of toxic compounds; control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and exclusion of pests from the food plant, as required by 21 CFR 123.11(c).
 
We reviewed your response to the FDA 483 received on April 1, 2014. Your response states you will activate and monitor the eight steps of sanitation. You also explain log sheets and procedures will be provided and set up with the help of the (b)(4). Please provide these documents when you have them implemented to show compliance with 21 CFR 123.11(c).
 
6.    Failure to wear outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.10(b)(1).  Specifically, an employee was observed manufacturing Seafood Gumbo and then packaging Seafood Gumbo while wearing a long sleeved sweat shirt. The edges of the sweat shirt were observed to repeatedly contact the inside of the finished product containers during the product filling operations.
 
We reviewed your response to the FDA 483 received on April 1, 2014. Your response states your policy and procedure will require all personnel to wear cloth or disposable aprons to ensure proper sanitation and protection of product. This response appears adequate and will be verified during our next inspection. 
 
Observations listed on the FDA 483 which were not addressed in this warning letter, will be verified for compliance during our next inspection. This letter is not intended to be an all-inclusive list of deficiencies in your plant. It is your responsibility to ensure all of your products comply with the Act, the Fish and Fishery Products regulations (21 CFR 123), Current Good Manufacturing Practice regulations (21 CFR 110), and other applicable regulations. The specific violations noted in this letter and on the FDA 483’s, issued at the close out of the inspections, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.
 
You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
 
Your response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter please contact Ms. Dutzek at (615) 366-7826.
 
Sincerely,
/S/                                                                       
Kimberly L. McMillian
Acting District Director
New Orleans District
 
 
cc:  Kyle G. Huxen, Jr., Co-Owner
 BEK, LLC dba Floppers Food
 19270 Scenic Highway 98                                                                     
 Fairhope, Alabama 36532-6825