Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
November 23, 2012
Paul C. Clark, Owner
Seafood Supply Company LP
1500 Griffin St. East
Dallas, Texas 75215
Dear Mr. Clark:
We inspected your seafood processing facility, Seafood Supply Company, LP, 1500 Griffin Street East, Dallas, Texas on June 14-22, 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 processed fish including, but not limited to, salmon and tuna and packaged seafood such as 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 John L. Fontanilla, Plant Manager, with the form FDA-483, Inspectional Observations, 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 HACCP plan for Fresh Processed Fish; Non-Scombroid Species which includes salmon, does not list the food safety hazards of parasites and pathogen growth or toxin formation for fish which is intended for raw consumption.
In addition, per 21 CFR 123.6(b)(2), you may group fish and fishery products if the food safety hazards, critical control points (CCP), critical limits, and procedures required to be identified and performed are identical for the products grouped. However, in review of your HACCP plans, your firm has grouped products with different food safety hazards. We recommend your firm's HACCP plans be reviewed and revised as needed.
Your written response dated November 19, 2012, submitted on your behalf by your Plant Manager, states your firm has now added a statement to your invoices that FDA recommends all raw fish be fully cooked before consumption. Your response is inadequate in that it fails to properly address the food safety hazards and fails to provide supporting documentation such as revised HACCP plan(s) for our review.
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 to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."
(a) However, your firm's HACCP plan for Fresh Processed Fish; Scombroid Species lists a critical limit "No Product will be accepted for processing having an internal temperature greater than 38 degrees F" at the receiving CCP that is not adequate to control pathogen growth and toxin formation and/or histamine formation as a result of time/temperature abuse.
(b) Your firm's HACCP plan for Fresh Prepackaged Product which includes pasteurized crabmeat lists a critical limit "Products packaged in a manner that would allow toxin formation will not be received if temperature exceeds 40 degrees F" at the receiving CCP that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum.
Your firm does not ensure the products are maintained at 40°F throughout transit. FDA recommends: (1) for fish or fishery products, delivered refrigerated (not frozen), that all lots received are accompanied by transportation records that show that the product was held at or below 40°F throughout transit; or (2) for products delivered under ice, that the product is completely surrounded by ice at the time of the delivery; or (3) for products delivered under chemical cooling media, such as gel packs, that there is an adequate quantity of cooling media that remain frozen to have maintained product at or below 40°F throughout transit and the internal temperature of the product at the time of the delivery is below 40°F or below; or (4) for products delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less, the time of transit does not exceed 4 hours and the temperature of the product at time of delivery does not exceed 40°F. Please refer to Chapters 7 and 13 of the HACCP Guide, 4th Edition, for the appropriate monitoring procedures, corrective action, verification procedures, and record keeping system that are applicable to critical limits established for your products.
Your written response is inadequate in that it does not properly address the deviation and does not establish one of the control strategies listed above or an equivalent process to control the food safety hazards reasonably likely to occur.
3. 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 Fresh Processed Fish; Scombroid Species lists monitoring procedures that are not adequate to control the food safety hazards of pathogen growth and toxin formation and/or histamine formation at the storage (in the processing room) critical control point. The monitoring procedure is inadequate because it fails to include monitoring for the length of time the scombroid species are exposed to unrefrigerated conditions above 40°F and ambient temperatures during the exposure periods.
In addition, this HACCP plan combines storage of products in two different areas (cooler and processing room) using different monitoring procedures and control strategies. Your HACCP plan should be revised to establish a separate cooler storage CCP. In addition, your critical limit states product will not be exposed to ambient temperatures above (b)(4)F for more than (b)(4) hours cumulatively, or for more than (b)(4) hours, cumulatively, if any portion of that time is at temperatures above (b)(4)F. During the inspection, our investigator observed your processing room to have a temperature of approximately 50°F and he was informed that product is stored in the processing room until distribution which may be in excess of 8 hours. Your firm should re-assess the length of time product is exposed to unrefrigerated conditions and make proper operational changes.
4. Because you chose to include corrective action plans in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans at the receiving and storage critical control points to control pathogens, Clostridium botulinum, and histamine hazards are not appropriate. For example:
(a) Your HACCP plans for Scombroid Species and Prepackaged Product (pasteurized crabmeat) list corrective action plans at the receiving CCPs that fail to include a corrective action to regain control over the operation after a critical limit deviation. Your plans should include discontinued use of the supplier until evidence is obtained that transportation handling practices have improved.
(b) Your HACCP plan for Prepackaged Product, including pasteurized crabmeat, lists a corrective action plan at the storage CCP that fails to include a corrective action to regain control over the operation after a critical limit deviation and determine the root cause of the deviation.
Your written response states revisions will be made to your corrective action plans. However, no revised HACCP plans were provided for our review or verification of promised corrections.
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 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 are aware your firm has other fish and fishery products and HACCP plans other than those listed in this letter. We request you review and evaluate your firm's HACCP plans to ensure all your products have appropriate HACCP plans established.
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