Inspections, Compliance, Enforcement, and Criminal Investigations
Absolutely Fresh Seafood Company 27-Dec-07
Department of Health and Human Services
Public Health Service
Kansas City District
Telephone: (913) 752-2100
December 27, 2007
RETURN RECEIPT REQUESTED
Ref. KAN 2008-02
Mr. Gregory N. Lindberg, Owner and President
Absolutely Fresh Seafood Company
1727 Leavenworth Street
Omaha, NE 68102-3142
Dear Mr. Lindberg:
We inspected your seafood processing facility, located at 1727 Leavenworth Street in Omaha, Nebraska on 9/11, 9/18, and 9/19/2007. 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 fish and fishery products 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 a HACCP plan for the pasteurized canned crab meat and cold smoked salmon you receive and handle/store to control the food safety hazard of Clostridium botullnum toxin formation.
• Your firm does not have a HACCP plan for the refrigerated vacuum packaged raw trout, marlin and swordfish you receive and handle/store to control Clostridium botulinum.
• 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." However, your firm's HACCP plan for:
• Vertebrate Seafood Products does not list the critical control point of "receiving" for controlling the food safety hazard of scombrotoxin (histamine) formation.
• Invertebrate Seafood Products does not list the critical control point of "receiving" for controlling the food safety hazard of pathogen growth and toxin formation, and, pathogens originating from the harvest water.
• Smoked Salmon does not list the critical control point of finished product "storage" to control pathogen growth and toxin formation.
• You must have a HACCP plan that, as a minimum; lists the critical limits that must be met at each of the critical control points, 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 (CCP) to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard". However, your firm's HACCP plans for Vertebrate Seafood Products and invertebrate Seafood Products list a critical limit "maintain the temperature of the processing floor at [redacted]F for refrigerated products," at the refrigerated "Storage" critical control point that is not adequate to control pathogen growth and toxin formation, and scombrotoxin (histamine) formation. We recommend a critical temperature limit of 40°F or less for control of histamine and pathogens during refrigerated storage.
• You must have a HACCP plan that, at a minimum, list monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c )(4). However,
• Your firm's HACCP plans for Vertebrate Seafood Products and Invertebrate Seafood Products list monitoring procedures and frequencies at the refrigerated "Storage" critical control points that are not adequate. These HACCP plans list that monitoring of room temperature will be performed [redacted] Performing intermittent checks only [redacted] does not ensure that adequate temperatures are maintained between those temperature checks. We suggest firms use equipment that is capable of providing a continuous record of the storage temperatures on a 24 hour a day basis in order to ensure that products are consistently maintained at proper storage temperatures. We also recommend a daily check of the temperature record and the equipment.
• Your firm's HACCP plan for smoked salmon lists monitoring procedures and frequencies at the "smoking/cooking" critical control point that are not adequate to control pathogen growth. Monitoring internal temperature of a salmon fillet [redacted] as listed in your plan will not adequately represent the temperature of the entire batch in the smoke house and a frequency of [redacted] will not ensure that the products were consistently maintained at the critical temperature limit for entire duration of the cook time, i.e., [redacted] for the entire [redacted] minute cook cycle as listed in your plan.
• 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 required for the processing of smoked salmon and invertebrate (i.e., raw shellfish) seafood products.
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.
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 facility 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 Food and Drug Administration, Attention: Amy E. Devine, Compliance Officer at the above address. If you have questions regarding any issues in this letter, please contact Rich Pendleton, Compliance Director, at (913) 752-2101.
John W. Thorsky
Kansas City District