| Public Health Service Food and Drug Administration |
Baltimore District Office |
Department of Health and Human ServicesFEI: 3003751705
WARNING LETTER
CMS #169274
May 2, 2011
Certified Mail
Return Receipt Requested
Mr. Kenneth R. Kell, President
Dani Jacq, Inc. dba The Home Fresh Foods Company
1806 Old Eastern Avenue
Baltimore, MD 21221-1429
Dear Mr. Kell:
We inspected your seafood processing facility, located at 1806 Old Eastern Avenue, Baltimore, MD 21221 on January 3 to January 18, 2011. 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 ready-to-eat Tuna Pasta Salads, ready-to-eat Shrimp Pasta Salads, Crab Soup, and Shrimp and Corn Chowder 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.
Your significant violations were as follows:
• 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However your firm does not have HACCP plans for:
a. Ready-to-eat Tuna Pasta Salad to control the food safety hazards of pathogen growth, histamine formation, and allergens.
b. Ready-to-eat Shrimp Pasta Salad to control the food safety hazards of pathogen growth, allergens, and food intolerance substances.
• 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:
a. “Crabmeat HACCP” which includes your Crab Soup does not list the food safety hazards of allergens;
b. “Soups, Non-Meat & Poultry”, which includes your Shrimp and Corn Chowder does not list the food safety hazards of allergens and food intolerance substances (sulfites).
• 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,
a. Your firm’s HACCP plan for “Crabmeat HACCP”, which includes your Crab Soup, does not list the critical control points for raw material storage (pasteurized canned crabmeat), cooking, processing (filling and cool-down), and finished product storage for controlling the food safety hazard of pathogens to include Clostridium botulinum toxin formation;
b. Your firm’s HACCP plan for “Soups, Non Meat & Poultry”, which includes your Shrimp and Corn Chowder does not list the critical control point for cooking, filling, and finished product storage for controlling the food safety hazard of pathogens to include C. botulinum toxin formation.
• You must implement the monitoring procedures and frequency that you have listed in your HACCP plan to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures for receiving pasteurized crabmeat upon the receipt of each shipment to control pathogen growth and toxin formation listed in your HACCP plan for “Crabmeat HACCP” which includes your Crab Soup. Specifically, a representative of your firm stated that you have not implemented monitoring procedures at the receiving pasteurized crabmeat critical control point to control pathogen growth and C. botulinum toxin formation. The monitoring procedures were not performed between January 5, 2010 and January 13, 2011.
• You must have a HACCP plan that lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm’s HACCP plan for “Crabmeat HACCP” for Crab Soup lists an inadequate monitoring procedure at the “Receiving Pasteurized Crabmeat” critical control point to control “Growth of the Pathogen C. botulinum”. Specifically, your monitoring procedure,
a. Under “What” states that you will monitor the “Temperature of a representative number of pasteurized crabmeat containers per shipment,” however you do not state whether you will be monitoring internal crabmeat container temperature or crabmeat container surface temperature.
b. Under “How” states that you will perform a “Visual check” to monitor temperature, however you do not list the instrument used to monitor the product temperature.
c. In addition, you do not list how you will ensure that transport time for transportation is less than 4 hours. Taking a one time temperature at receipt is adequate only when transit times are short, for example under 4 hours.
• Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for “Crabmeat HACCP” for Crab Soup at the “Receiving Pasteurized Crabmeat” critical control point to control “Growth of the Pathogen C. botulinum” is not appropriate. You do not list how you will correct the cause of the deviations, for example, discontinuing use of the supplier until evidence is obtained that transportation handling practices have improved.
• 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 “Soups, Non Meat & Poultry”, which includes your Shrimp and Corn Chowder, lists a critical limit (b)(4) at the “Chilling Finished Product” critical control point that is not adequate to control pathogen growth and toxin formation. Specifically, you fail to list an actual value.
We received your letter dated February 21, 2011 responding to the FDA-483 issued on 1/18/11 and re-issued as Amendment 1 on 1/28/11. We have evaluated your response. Although you begin to address FDA’s concerns, your response does not adequately address the observations noted in the FDA-483.
Your firm has disconnected the continuous temperature recorder of your walk-in coolers, and you currently monitor the temperature of the walk-in coolers visually. FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we recommend a daily check of the recorded temperatures to ensure that readings are accurate, and a daily check of the monitoring equipment itself to ensure that it is operating properly.
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov
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, and the seafood HACCP regulation (21 CFR Part 123). 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: Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Cherlita Honeycutt at (410) 779-5412 or via e-mail at Cherlita.Honeycutt@fda.hhs.gov.
Sincerely yours,
/s/
Evelyn Bonnin
District Director
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