Inspections, Compliance, Enforcement, and Criminal Investigations
H & H Seafood 1/30/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
January 30, 2013
Sent via UPS Overnight
Torry Hill, Co-Owner
Lewis Morales, Co-Owner
H & H Seafood Company
1440 Cedar Post Lane
Houston, Texas 77055-4306
Dear Messrs. Hill and Morales:
We inspected your seafood processing facility, H & H Seafood, 1440 Cedar Post Lane, Houston, Texas on September 10-13, 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 (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 fresh scombroid species, refrigerated ready-to-eat crabmeat and pasteurized canned crabmeat, 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.
At the close of our inspection, the investigator provided your Manager, with the form FDA 483, which presents an evaluation of your firm's performance regarding various aspects of the HACCP requirements. We have attached a copy of the FDA 483 for your reference.
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 sole HACCP plan titled "HACCP PLAN FOR PROCEDURES OF SAFE AND SANITARY PROCESSING OF FRESH AND FROZEN FISH AND FISHERY PRODUCTS" (HACCP plan) does not list the food safety hazards for the fish and fishery product your firm processes. For example,
a. Your firm's HACCP Plan does not list the food safety hazard of histamine formation for fresh scombroid species such as mahi-mahi and tuna.
b. Your firm's HACCP Plan does not list the food safety hazard of Clostridium botulinum for pasteurized canned crabmeat.
c. Your firm's HACCP Plan does not list the food safety hazard of pathogen growth and toxin formation for refrigerated ready-to-eat crabmeat.
In addition, per 21 CFR 123.6(b)(2), you may group fish and fishery products if the food safety hazards, critical control points (CCPs), critical limits, and procedures required to be identified and performed are identical for the products grouped. However in review of your HACCP plan your firm has grouped products with different food safety hazards. We recommend your firm's HACCP plan be reviewed and revised to address the different food safety hazard."
2. 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 (CCP) to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."
a. Your firm's HACCP plan for pasteurized canned and refrigerated ready-to-eat crabmeat lists a critical limit at the receiving CCP that is not adequate to control pathogen growth and toxin formation, including Clostridium botulinum. Your plan states, "All incoming product must be checked for proper temperature with thermometer, visual check on ice pack (iced fresh (b)(4) to (b)(4) degrees)" does not ensure that refrigerated fishery products have been held at or below an ambient or internal temperature of 40°F throughout transit.
b. Your firm's HACCP plan for pasteurized canned and refrigerated ready-to-eat crabmeat lists a critical limit at the storage CCP that is not adequate to control pathogen growth and toxin formation, including Clostridium botulinum. Your plan states "Temperature must be inspected (b)(4) and maintained at (b)(4) to (b)(4) degrees in the cooler with a visual ice check and (b)(4) to (b)(4) degrees in the freezer" does not ensure that crabmeat product have been stored at or below an ambient or internal temperature of 40°F or completely and continuously covered by ice throughout storage.
c. Your firm 's HACCP plan for fresh scombroid species lists a critical limit at the storage CCP that is not adequate to control histamine formation. Your plan states "All fresh fish must be packed in ice and visually inspected (b)(4) Tuna, Mahi Mahi, and Amberjack will be stored in a temperature monitored cooler" does not ensure that fresh fish has been stored at or below an ambient or internal temperature of 40°F or completely and continuously covered by ice throughout storage.
3. You must implement the records keeping system that your listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the receiving or storage critical control points listed in your HACCP plan to control histamine formation for fresh scombroid species and pathogen growth and toxin formation for pasteurized canned crabmeat and refrigerated ready-to-eat crabmeat.
4. 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 plan for fresh fish or fishery products, such as fresh scombroid species to control histamine formation and for crabmeat, to control pathogen growth and toxin formation at the receiving critical control point is not appropriate.
Your receiving CCP corrective action covers all products received by your firm. Your plan states "If any of the hazards are noted by visual or temp taken the product will be returned to the shipper or disposed of."
Your corrective action does not provide for correction of the cause of the deviation when the critical limit is exceeded or a corrective action to regain control over the operation after a critical limit deviation. Your plan should include discontinued use of the supplier until evidence of transportation handling practices are improved.
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)(8)). 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 of 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations. We request you review and evaluate your firm's HACCP plan to ensure all your seafood products have appropriate HACCP plans.
Please send your reply to the Food and Drug Administration, Attention: Elvia J. Cervantes, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Ms. Cervantes at 214-253-5236.
Reynaldo R. Rodriguez, Jr.
Dallas District Director