| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human Services
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Jerry Walker, CEO
Choice Food Group, Inc.
618 Church Street
Nashville, Tennessee 37219
Dear Mr. Walker:
On August 3 through 5, 2010, U.S. Food and Drug Administration (FDA) investigators inspected your seafood processing facility, American Seafood Company, Inc., located at 3657 Old Getwell Road, Memphis, Tennessee. 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 (CGMP) regulation for foods, 21 CFR 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 to comply with this section or otherwise operate in accordance with the requirements of 21 CFR 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), Title 21, United States Code, Section 342(a)(4). Accordingly, your seafood products are adulterated, because 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:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and 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 that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). Your firm does not have HACCP plans for the following products:
A. Raw, refrigerated tuna (not vacuum packaged) intended for raw consumption by the consumer or end-user to control the food safety hazards of pathogens and histamine formation;
B. Vacuum packaged (i.e., sealed oxygen-limiting packaging) raw, refrigerated tuna intended for raw consumption by the consumer or end-user to control the food safety hazards of histamine formation and pathogen growth and toxin formation specifically from Clostridium botulinum; and,
C. Raw, refrigerated salmon intended for raw consumption by the consumer or end-user to control the food safety hazard of pathogen growth.
Parasites are a food safety hazard associated with wild caught salmon, and in some instances also with aquaculture-raised salmon. Chapter 5 of the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, can provide additional information to aid in your hazard analysis for your salmon product.
2. You must implement the monitoring procedures and frequency you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not implement your monitoring procedure of “Continuing recording thermometer” and “Continuous” monitoring of “Temp.” at the Storage critical control point listed in your HACCP plan for “Scombroid or Other Histamine Producers.” Your firm’s monitoring records for the continuous recording/alarm monitored thermometer do not include temperature readings, thus your monitoring of “Temp.” coupled with your listed critical limit of “not above 40° for more than 4 hours” can not be implemented.
3. You must have a HACCP plan which, at a minimum, lists the critical limits which 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 (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 “Fresh Crabmeat, Pasteurized Crabmeat” and “Scombroid or Other Histamine Producers” list inadequate critical limits. Specifically:
• Your HACCP plan for “Fresh Crabmeat, Pasteurized Crabmeat” lists a temperature limit of 45º F at the receiving CCP which is not adequate to control the food safety hazard of pathogen growth and toxin formation. FDA recommends a temperature critical limit of 40 º F or below for controlling pathogen growth in ready-to-eat products such as your pasteurized crabmeat product and fresh crabmeat packed in tubs (i.e., fresh crab meat not sealed oxygen limiting packaging materials).
• Your HACCP plan for “Shellfish” lists a temperature limit of 45º F at the receiving CCP which is not adequate to control the food safety hazard of pathogen growth. FDA recommends a temperature critical limit of 40º F or below for controlling pathogen growth.
• Your HACCP plan for “Scombroid or Other Histamine Producers” does not list a critical limit at the Receiving CCP to assure safe conditions were maintained during the transit period to your facility for controlling the food safety hazard(s) of pathogen growth and histamine. “Continuing certificates of guarantee”, as listed in your plan, are not adequate controls at receiving. FDA recommends that processors ensure products received were maintained at appropriate temperatures during transit to the facility. FDA suggests monitoring for a temperature critical limit of 40° F for products received under refrigeration; or, alternatively, monitoring for the presence of adequate ice or cooling media surrounding the product when products are received on ice or with cooling media.
As mentioned above, raw fresh products packed in sealed oxygen-limiting packaging pose a hazard specifically for Clostridium botulinum growth and toxin formation; and, therefore, need holding temperatures maintained at or below 38º F to prevent toxin development.
Chapters 7 or 12 of the Fish and Fisheries Products Hazards & Controls Guidance: Third Edition can provide you with information to help you choose the method best suited to your situation.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). Your firm did not monitor prevention of cross-contamination from insanitary objects and the protection of food, food packaging material, and other food contact surfaces, and protection of food, food packaging material, and food contact surfaces from adulteration with condensate and other chemical, physical, and biological contaminants with sufficient frequency to ensure compliance with the CGMP requirements in 21 CFR 110 as evidenced by:
• On August 3, 2010, employees were observed in the cutting room processing salmon and halibut without wearing hair restraints or plastic sleeves and no chlorine was detected in the ice shovel sanitizing dip solution bucket at 3:30 pm.
• On August 4, 2010, chlorine was detected at 50 ppm in the ice shovel sanitizing dip solution bucket.
• On August 3 and 4, 2010, the floor had large cracks near areas where water drained. These cracks held water and standing water was observed in the cracks after clean-up procedures were performed. Peeling paint and rust were observed on the walls. A leaking ceiling pipe dripped condensate onto a box containing scrap amberjack fish bones. Management stated scrap fish bones are sometimes sold as stock to restaurants.
After further record review, the following deficiencies were noted:
• 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 which, at a minimum, lists the CCPs, to comply with 21 CFR 123.6(a) and (c) (2). A 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 “Fresh Crabmeat, Pasteurized Crabmeat” does not list the CCP of storage for controlling the food safety hazard(s) of pathogen growth and potential toxin formation.
• 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). Your corrective action plan for “Scombroid or Other Histamine Producers” at the Storage CCP to control histamines is not appropriate. Should the scombroid, or other histamine producing fish, be above 40° F for more than 4 hours, your firm’s corrective action is to “add ice”. However, you do not state what other corrective action you would take, such as destroying the affected product, diverting the product to non-food use, or conducting a histamine analysis.
• You must have a HACCP plan which, at a minimum, lists monitoring procedures and their frequency for each CCP, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “Scombroid or Other Histamine Producers” does not list monitoring procedures: to assure the listed critical limit of not above 40° F for more than 4 hours is met; of checking the function of equipment daily; and, to review temperature recording charts daily at the Storage CCP to control histamines.
Additionally, FDA noted, during review of your records based on your Product Guide, there are multiple seafood products you could potentially receive and store. Any seafood products you hold for distribution must have a hazard analysis conducted to determine whether there are food safety hazards which are reasonably likely to occur, and, if necessary, have and implement a written HACCP plan for those fishery products to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b).
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violations. You should include in your response documentation such as HACCP and verification records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, 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 CGMP regulation (21 CFR 110). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Ms. Asente at (504) 219-8818 extension 104.
Sincerely,
/s/
H. Tyler Thornburg
District Director
New Orleans District
Enclosure: Form FDA 483, dated August 5, 2010
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