| Public Health Service Food and Drug Administration |
| Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139 |
Department of Health and Human Services
WARNING LETTER
2011-DET-06
February 24, 2011
VIA UPS
My. James D. Gordon, President/Owner
Gordon Food Service, Inc.
333 50th Street, SW
Grand Rapids, MI 49548
Dear My. Gordon:
We inspected your seafood processing facility, located at 7770 Kensington Court, Brighton, MI 48116-8416 on October 29 through November 12, 2010. 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, 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 refrigerated tuna salad and refrigerated raw shucked scallops 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:
1. 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 titled "HACCP PLAN FOR PROCESSED SEAFOOD" for refrigerated tuna salad does not list the food safety hazards of scombrotoxin (histamine) formation, and pathogen growth and toxin formation.
We note that your "HACCP PLAN FOR PROCESSED SEAFOOD" consists of a Hazard Analysis Worksheet which incorrectly concludes that no hazards were identified for any of your processing steps. In your November 23, 2010, letter in response to the FDA 483 observations, you indicate that your "tuna salad items...are made with cooked tuna" and "There is no hazard for histamine production in cooked tuna." Proper retorting of the tuna in cans or retort pouches will destroy pathogens, organisms and enzymes responsible for scombrotoxin formation. However, once the can or pouch of retorted tuna is opened and exposed to recontamination from the air, processing environment, and the inclusion of other ingredients during the making of the tuna salad product, pathogens and organisms responsible for scombrotoxin formation are reintroduced to the tuna meat, and given uncontrolled time-temperature conditions conducive to growth, the hazards are once again likely to occur. In addition, because your tuna salad is a ready-to-eat product, pathogen growth and toxin formation are reasonably likely hazards that your firm needs to control with an effectively implemented written HACCP plan.
For additional information related to the hazards of histamine (scombrotoxin) formation, please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.
• However, your firm's HACCP plan titled "HACCP PLAN FOR INVERTEBRATE GROUP 2," for refrigerated (iced) raw shucked scallops meat in metal cans does not list the food safety hazard of Clostridium botulinum toxin formation.
Your document titled "HACCP PLAN FOR INVERTEBRATE GROUP 2" consists of only a Hazard Analysis Worksheet which incorrectly concludes that no hazards were identified as pertinent to any of your processing steps. The raw scallop meat containers observed by FDA investigators at your facility were metal containers with friction closure lids similar to paint cans. In your November 23, 2010, letter in response to the FDA 483 observations, you indicate that your "fresh canned scallops...do not have the risk of C. botulinum because they are in a can similar to a paint can that has not undergone thermal processing, so it is not an anaerobic environment that would support the growth of C. botulinum." FDA recognizes that the product in these cans has not undergone a thermal process. In the absence of an adequate thermal process, Clostridium botulinum bacteria and spores will not have been destroyed and, therefore are expected to be viable in the containers of product. We understand that there was no known vacuum drawn or gas injection (controlled or modified), nor thermal application (e.g. hot fill), applied when packaging the product whereby a reduced oxygen environment was deliberately created in the closed can. However, while there may initially be trapped oxygen when the can is sealed, and there may be some oxygen transmission through the non-hermetically sealed lid ridge, there will also be a consumption of available oxygen during normal respiration of bacterial activity in the raw product, especially if the product is subject to abusive time-temperature exposures. Because the metal can itself is clearly not oxygen permeable and, while there may be the possibility of slight oxygen replenishing at the surface of the container through the lid seal, the development of an anaerobic environment conducive to the botulinum toxin hazard deeper in the can is considered reasonably likely. Unless your firm has scientific evidence to show that the oxygen transmission through the lid seam is sufficient to inhibit Clostridium botulinum growth and toxin formation throughout the container during time-temperature abuse, or that spoilage of the product in these containers will occur well in advance of toxin formation during time-temperature abuse, than your firm needs to control the hazard with an effectively implemented written HACCP plan.
For information concerning the hazards of pathogens and Clostridium botulinum toxin formation please refer to chapters 12 and 13 of the Hazards Guide.
We note that your hazard analyses do not distinguish between refrigerated and frozen product which could affect the hazards that need to be controlled. Also, while your hazard analyses suggest that all the fish and fishery products handled by your firm are intended to be fully cooked by consumers, if you identify any of your buyers to be associated with the raw consumption market, your hazard analysis of the affected refrigerated products may well identify previously dismissed hazards that you may need to control through an appropriate written and implemented HACCP plan.
In addition, your firm might consider regrouping your products for hazard analysis purposes on the basis of hazards germane to your operation as a secondary processor and include process, package, and potential end-use related hazards that could affect the controls pertinent to your products.
2. You must have a HACCP plan that, at a minimum, 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 plans for Vertebrate Groups 6, 7, 8, and 9, which cover various scombrotoxin (histamine) forming fish, list monitoring procedures and frequencies, that are not adequate to control scombrotoxin formation. Specifically,
• At the "Receiving" critical control point, your HACCP plan lists "Visual examination" for the "Adequacy of ice surrounding product" in "Every lot at receiving." However, the monitoring procedures do not instruct how many units are to be examined in each lot received. FDA recommends monitoring of a sufficient number of containers (e.g. cartons) to represent all of the product in the lot. Your monitoring records should provide a positive reflection of the number of units examined compared to the number of units in the lot, or a percentage of units examined, to properly document the actual observations made were sufficiently representative of the lot.
• At the "Storage" critical control point, your HACCP plan lists only a "Daily" "Visual examination" for the "Adequacy of ice surrounding product." FDA recommends a monitoring frequency of at least twice daily checks for adequacy of ice during refrigerated (iced) storage. Again, the monitoring should be of a sufficient number of containers (e.g. cartons) from each of the lots to represent all of the product in all of the lots in the storage coolers. Your monitoring records should provide a positive reflection of the number of units examined compared to the number of units in each lot and the number of lots in the coolers, to properly document that the actual observations made were sufficiently representative of all lots. In a very large warehouse, this can become cumbersome to accomplish in a meaningfully manner. But, because various lots may contain products of different sizes and configurations and residence time and exposures in the coolers, control is achieved only by sufficient coverage during monitoring. Your firm may want to consider if continuous time-temperature monitoring devices in the coolers, with appropriate critical limits, may be a more advantageous monitoring strategy for refrigerated storage of your fish and fishery products.
3. 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, the corrective action plans listed in your HACCP plans for Vertebrate Groups 6,7,8, and 9,10, and 11, which cover various scombrotoxin (histamine) forming fish, at the receiving and storage critical control points, are not appropriate to control scombrotoxin (histamine) formation are not appropriate. Specifically,
• The corrective actions listed at your "Receiving" and your "Storage" critical control points, state "Reject product" and "Destroy product," respectively. Unless 100% of the product is examined during the monitoring, the inference of the units examined should extend to the entire lot and appropriate corrective action should, therefore, be taken on the entire lot accordingly, not just on portions of product that happened to be observed with inadequate ice.
• Your listed corrective actions do not address how the cause of a critical limit deviation will be corrected. FDA recommends that, in addition to rejection of the lot at receipt, that you discontinue use of the supplier until evidence is obtained that transportation handling practices have been improved. Likewise, FDA recommends that, in addition to destruction of the lot at storage, that you take additional steps (e.g., make repairs or adjustments to the cooler, or modify the process) to regain control over the operation and to prevent reoccurrence of the deviation.
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.
In addition, we offer the following comments based on our review of your HACCP plans and your manufacturing operations.
1. FDA did not include your herring product from Vertebrate Group 10 or your snapper product from Vertebrate Group 11 in the above citations despite your identifying them with the scombrotoxin (histamine) hazard. The herring were not listed above because your "HACCP PLAN FOR VERTEBRATE GROUP 10" states that the product is "Stored and shipped in a frozen state." We note that this conflicts with your "Hazard Analysis Worksheet" and "HACCP Plan Form" that follow which address the fish as if it is in the refrigerated state. If, in fact, you receive and store the herring in a refrigerated state, the scombrotoxin citations above, as well as other potential hazards depending on the packaging and intended use, may be pertinent to the herring product. The snapper were not included in the letter because FDA has determined that snapper do not present a scombrotoxin (histamine) hazard.
2. We note that your firm's HACCP plans for Vertebrate Groups 6, 7, 8, and 9, which cover various scombrotoxin (histamine) forming fish, do not list adequate verification procedures and frequencies at your "Receiving" or "Storage" critical control points to verify the effective implementation of the monitoring procedures of "Visual examination[s]" for the "Adequacy of ice surrounding product" to control the hazard of scombrotoxin (histamine) formation. FDA recommends that processors relying on visual checks of ice or cooling media to monitor adequate cooling of product, periodically measure internal temperatures of fish to ensure that the ice or cooling media is sufficient to maintain product temperatures at 40°F or less. A good time to conduct these verifications is when lots are observed with marginally acceptable levels of ice or coolant. Verification checks of the temperatures of product should be directed at any exposed edible portions of fish and near surface temperatures of the fish as well as deep core temperatures.
3. Investigators observed potential sanitation monitoring and record-keeping deficiencies at your facility during the inspection. Your firm should ensure that it complies with the sanitation control procedures provisions of 21 CFR 123.11. While all eight elements of sanitation may not be applicable to your operations, you must monitor conditions and practices, and maintain sanitation control records, for those elements that are applicable to your operations.
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, 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 U.S. Food and Drug Administration, Attention: Michael V. Owens, 300 River Place Suite 5900, Detroit, Michigan 48207. If you have questions regarding any issues in this letter, please contact Mr. Owens at (313) 393-8100, extension 8167.
Sincerely,
/S/
Joann M. Givens
Detroit District Director
Detroit District Office
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