Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
February 28, 2013
Robert Hallam, Chairman and Chief Executive Officer
Ben E. Keith Company
601 E. Seventh Street
Ft. Worth, Texas 76113
Dear Mr. Hallam:
We inspected your seafood processing facility, located at 5505 Kaepa Court, San Antonio, Texas on November 27, 2012 to December 6, 2012. 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 canned crabmeat, lump crabmeat, seafood salads, and fresh tuna 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.
We acknowledge receipt of a letter dated December 20, 2012, from the San Antonio facility’s Assistant General Manager, Mr. Doak Pierce, and revised, undated HACCP plans, received February 12, 2013. However, review of these documents reveals that your firm has not made complete corrections to the observations made during the inspection, as noted below.
Your significant violations are 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 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, the following HACCP plans fail to list hazards that are likely to occur:
A. Your canned crabmeat and lump crabmeat plans do not list the food safety hazard of pathogenic bacteria growth and toxin production, and
B. Your HACCP plan for fresh tuna does not list the hazard of scombrotoxin (histamine) formation.
- 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 plans list critical limits at receiving and storage that are not adequate to control the hazards that are likely to occur, as follows:
A. Your canned crabmeat and lump crabmeat HACCP plans list receiving critical limits of “inbound product cooler (b)(4) or below”. FDA recommends your critical limit include that all lots received are accompanied by transit records that show that the product was held at or below an ambient or internal temperature of 40°F or below throughout transit. The Fourth Edition of the Fish and Fishery Products Hazards and Controls Guidance also contains other options, including those for use when products are received on ice.
B. Your canned crabmeat and lump crabmeat HACCP plans list storage critical limits of “vault exceeds specified ranges in specific vaults stated on (b)(4) temp logs”. Thus it appears that the specifics of the critical limits - i.e., the ambient cooler temperature limit - are listed on the “(b)(4) temp logs”. However, these temp logs are not included in your plan, and therefore your critical limit is incomplete. You did not provide the (b)(4) temp logs with your response, so it is unknown what your critical limits are; however, FDA recommends a critical limit of an ambient cooler temperature of 40°F or below.
C. Your fresh tuna HACCP plan lists a receiving critical limit of “product must be packed in ice when received.” FDA recommends that when fish are received on ice, an appropriate critical limit to control the hazard of scombrotoxin formation is that fish are completely surrounded by ice at the time of delivery.
D. Your seafood salads HACCP plan lists a receiving critical limit of “ambient temperature must be less than (b)(4) deg F when received”. However, as stated above, FDA recommends your critical limit include that all lots received are accompanied by transit records that show the temperature was maintained at or below 40°F throughout transit.
- 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 fresh tuna and seafood salads list monitoring procedures and/or frequencies at the storage critical control points that are not adequate to control the hazards likely to occur:
A. Your fresh tuna HACCP plan lists the two-part critical limit of “product must be stored in ice” and “storage vault must be below (b)(4) deg” with monitoring procedures of checking for (b)(4) and (b)(4) checks of the vault temperature. FDA recommends that you employ continuous temperature monitoring when monitoring for a cooler ambient temperature critical limit. However, if the presence of ice is your primary method of temperature control of the fish, then an appropriate critical limit is that fish are completely surrounded by ice during storage.
B. Your seafood salads HACCP plan lists (b)(4) monitoring of the storage temperature of the storage vault. FDA recommends that you employ continuous temperature monitoring of the cooler(s) where seafood salads are held.
- 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 plans for canned crabmeat, lump crabmeat, seafood salads, and fresh tuna are not appropriate as follows:
A. Your HACCP plans for canned crabmeat, lump crabmeat, fresh tuna, and seafood salads list corrective actions at the receiving CCP that include rejections of the shipment, and, in the case of fresh tuna and seafood salads, to notify the carrier of the non-compliance. However, FDA recommends these corrective actions include discontinuing use of the carrier until evidence is obtained that transportation and handling practices have been improved.
B. Your HACCP plan for Seafood Salads lists a corrective action of, “destroy product stored in temperature exceeding (b)(4) deg F” at the storage CCP. However, FDA recommends that you also determine and correct the cause of the non-compliance. Effective corrective action plans must correct and eliminate the cause of the noncompliance to assure that the CCP is brought back under control, as well as rejecting or determining the disposition of the noncompliant product.
Please be advised that if you make changes to your plans to correct the above-listed deficiencies, you will also need to review the remainder of each critical control point to ensure that all aspects of your HACCP plans are adequate to control the hazards that are likely to occur. 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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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 Food and Drug Administration, Attention: Seri Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Ms. Essaryat (214)253-5335.
Reynaldo R. Rodriguez, Jr.
Cc: Michael Needham, General Manager
Ben E. Keith Company
5505 Kaepa Ct.
San Antonio, TX 78218-5547