- Brookshire Brothers Inc.
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District Office|
4040 North Central Expressway
Dallas, Texas 75204-3128
December 8, 2015
Jerry Johnson, President & CEO
Brookshire Brothers, Inc.
1201 Ellen Trout Drive
Lufkin, TX 75904
Dear Mr. Johnson:
We inspected your facility, located at 2608 Martin Luther King Blvd., Lufkin, TX 75904, on October 27 through October 30, 2015.
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 Salad and ready-to-eat Supreme Salad areadulterated, in that they have been prepared, packed, or held under insanitary conditions wherebythey 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 (HACCP Guide) 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 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 ready-to-eat (RTE) Supreme Salad to control the food safety hazards of Clostridium botulinum toxin formation and pathogenic bacteria growth.
2. 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 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 RTE Tuna Salad does not list the food safety hazard of Undeclared Allergens at the Receiving critical control point, and does not list Clostridium botulinum toxin formation at the Receiving and Storage critical control points, which are reasonably likely to occur in your five-pound tubs of Tuna Salad.
3. 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 21 123.3(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 RTE Tuna Salad lists critical limits at the Receiving critical control point that are not adequate to control the allergen, scombrotoxin (histamine) formation, Clostridium botulinum, and pathogenic bacteria growth and toxin formation.
a. At the Receiving CCP, your HACCP plan lists the critical limit “(b)(4).” This critical limit does not ensure product is maintained at or below 40°F throughout transit, to control the scombrotoxin, Clostridium botulinum, and pathogenic bacteria growth and toxin formation hazards. The HACCP Guide identifies various control strategies for receiving seafood products, including receiving seafood accompanied by transportation records showing the product was held at 40°F or below throughout transit; or, if the transit time was less than four hours, that the internal temperature of the product at the time of receipt was 40°F or less.
Additionally, even if your critical limit was adequate, your monitoring procedure and frequency of checking the product temperature “(b)(4)” listed in your HACCP plan is not adequate to control the above hazards. Once an adequate critical limit is established, you should implement the appropriate monitoring procedures and frequencies to demonstrate all lots received meet your critical limit.
b. At the Receiving CCP, your HACCP plan lists the critical limit of “(b)(4).” This critical limit does not ensure all finished product packages display a label that contains an allergen declaration, including the allergens of eggs, fish, soy, and FD&C Yellow #5.
4. 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 plan for RTE Tuna Salad lists a monitoring frequency at the Storage critical control point that is not adequate to control the scombrotoxin, Clostridium botulinum, and pathogenic bacteria growth and toxin formation hazards. Specifically, your HACCP plan lists a monitoring frequency of “(b)(4).” The cooler temperature should be monitored continuously, with a daily visual check to ensure your critical limit is met.
5. 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 RTE Tuna Salad at the Receiving and Storage critical control points are not appropriate.
a. Your corrective action plan at the Receiving critical control point to control your allergen hazard does not address how you will regain control over the critical limit deviation. The HACCP Guide recommends several strategies to regain control, including discontinuing the use of the supplier until evidence is obtained that labeling contains the appropriate declarations.
b. Your corrective action plan at the Receiving critical control point to control the scombrotoxin, Clostridium botulinum, and pathogenic bacteria growth and toxin formation hazards does not address how you will regain control over the operation after a critical limit deviation. The HACCP Guide recommends discontinuing the use of the supplier until evidence is obtained that transportation practices have improved.
c. Your corrective action plan at the Storage critical control point to control the scombrotoxin, Clostridium botulinum, and pathogenic bacteria growth and toxin formation hazards does not address how you will prevent further deterioration of the product exposed to a critical limit deviation.
6. You must review critical control point monitoring records within one week after the records are made, to ensure compliance with 21 CFR 123.8(a)(3). Specifically, you did not review your (b)(4) Temperature Logs for your cooler, dated August 13, 2015 through October 28, 2015, nor did you review the (b)(4) computer temperature records for October 5, 19, or 26, 2015.
7. Your HACCP plan must include on-going verification activities, including calibration of process monitoring instruments, to comply with 21 CFR 123.8(a)(2). Your HACCP plan does not include verifying the accuracy of and/or calibration of your thermometers and temperature monitoring instruments used to monitor the critical control points at Receiving and Storage.
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.
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 an updated HACCP plan, critical control point monitoring records, calibration 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.
In addition, 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). During the inspection, our investigator noted you did not consistently document your sanitation monitoring activities, nor were you monitoring the proper labeling, storage, and use of toxic compounds and the exclusion of pests. Sanitation control records must be maintained, and the information must be documented on the record at the time the activity was observed.
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.
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 he 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.
Please send your reply to the Food and Drug Administration, Attention: Jamie M. Bumpas, Compliance Officer, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Jamie M. Bumpas at 214-253-5336.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
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