Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
May 1, 2014
RETURN RECEIPT REQUESTED
Robert P. Martin, President/Owner
Sea Fex, Inc. dba Seafood Express
766 Indian Creek Road
Telford, PA 18969
Dear Mr. Martin:
We inspected your seafood processing facility, located at 766 Indian Creek Road, Telford, PA from March 26, 2014 through March 31, 2014. Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 seafood products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, FDA regulations, and the Fish and Fisheries Product Hazards & Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov. We found that you have serious violations of the
We acknowledge your response letter, dated April 14, 2014, concerning our investigator’s observations listed on the Form FDA-483, Inspectional Observations issued to you at the close of the inspection, on March 31, 2014. We address this response below as it relates to the noted observations.
Your significant violations were as follows:
1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan, received with your response, for RTE Canned Refrigerated Pasteurized Crabmeat lists a monitoring procedure at the “Receiving” CCP that is not adequate to control Clostridium botulinum toxin formation. Specifically, the monitoring procedure under the column of “How” states “(b)(4)”. FDA recommends that secondary processors monitor receipt of products that are delivered via a refrigerated vehicle through the review of records from the vehicles continuous temperature-recording device (recording thermometer) used during transit to ensure product temperatures met the critical limit (CL), listed in the HACCP plan (FDA-483 Observation 1a).
2. 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). However, your firm did not maintain sanitation monitoring records for monthly monitoring of: the safety of water that comes into contact with food or food contact surfaces; the condition and cleanliness of food contact surfaces; and the prevention of cross-contamination from insanitary objects to food, as required. Moreover, our investigator found that your firm had not completed the “Monthly Sanitation Monitoring” record since August 31, 2012 (FDA-483 Observation 2c).
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures/frequency for the presence of a third party certificate indicating that the producer operates under a third party-audited quality assurance program at receiving CCP to control the aquaculture drug hazard listed in your HACCP plan for Farm Raised Rainbow Trout and Barramundi, which was reviewed during the inspection. This is a repeat violation from our October 2010 and March 2008 inspections. In addition, the revised HACCP plan for Rainbow Trout and Barramundi, received with your response, is not adequate and appears to be copied from your HACCP plan for Fresh Mahi Mahi Fillets, Tuna, Amberjack, Blue Fish, Marlin, Shad, and Escolar. (FDA-483 Observation 3).
4. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective actions listed in your revised HACCP plans, that were provided with your response, for Canned Refrigerated Pasteurized Crabmeat and your HACCP plan for Fresh Mahi Mahi Fillets, Tuna, Amberjack, Blue Fish, Marlin, Shad, and Escolar, at the cooler storage CCP, to control the hazards of Clostridium botulinum growth & toxin formation and the hazard of Scombrotoxin (histamine) formation, respectively, are not appropriate. For Canned Refrigerated Pasteurized Crabmeat, the cooler storage CCP lists the corrective action “(b)(4)”. This corrective action fails to ensure adulterated product does not enter commerce, for example, by chilling and holding the affected product until an evaluation of the total time and temperature exposure is performed or destroying the product, or diverting product to a non-food use. For Fresh Mahi Mahi Fillets, Tuna, Amberjack, Blue Fish, Marlin, Shad, and Escolar, the cooler storage CCP lists the corrective action “(b)(4)”. This corrective action fails to ensure adulterated product does not enter commerce, for example, by chilling and holding the affected product until an evaluation of the total time and temperature exposure is performed. Further, it does not regain control over the operation by addressing the root cause, for example, making repairs or adjustment to the malfunctioning cooler or by making adjustments to the ice application operations. (FDA-483 Observation 5b)
5. You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels. However, your firm’s revised HACCP plan, received with your written response, for Fresh Mahi Mahi Fillets, Tuna, Amberjack, Blue Fish, Marlin, Shad, & Escolar, your revised HACCP plan for Rainbow Trout and Barramundi, and your revised HACCP plan for non-scombrotoxin finfish (cod and monkfish), do not list the critical control point of “Finished Product Labeling” for controlling the food safety hazard of undeclared major food allergens (FDA-483 Observation 6 & 7).
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 to the above violations, based on our review of your revised HACCP plans which were provided with your written response, we have the following recommendations.
6. For your revised HACCP plan for RTE Canned Refrigerated Pasteurized Crabmeat, at the “Receiving” CCP, we recommend that the column under “Records” list “a visual check of the recorded data from the results of the continuous temperature monitoring device”. Additionally, “Verification” should list “quarterly accuracy check of the vehicle’s continuous recording device, accuracy of stem thermometer used to verify recorder should be checked daily before the beginning of operations, and a weekly review of corrective action and verification records”. The “Cooler Storage” CCP under the column “Verification” should list “daily accuracy check of the cooler’s continuous recording device, as well as a weekly review of corrective actions and verification records”.
Further, we recommend that your revised HACCP plan for Fresh Mahi Mahi Fillets, Tuna, Amberjack, Blue Fish, Marlin, Shad, and Escolar, at the “Receiving” CCP, should list in the “Records” column, “the number of containers examined and the sufficiency of ice for each container and the number of containers in the entire lot”. Also, the “Verification” column should list the “weekly review of monitoring, corrective action, and verification records”. Additionally, the “Cooler Storage” CCP under the column “Records” should list the “number of containers examined and the sufficiency of ice for each container and the number of containers in the entire lot”. The “Verification” column should list the “periodic measurement of internal temperatures, and weekly review of monitoring, corrective action, and verification records”.
Additionally, we acknowledge that you placed an order for a continuous temperature recording device, based on an email dated April 7, 2014 from the supplier, provided with your written response. We recommend that you install this device as soon as possible so that proper monitoring of products in your refrigerated storage can begin. Your firm’s failure to continuously monitor refrigerated product has been a recurring deficiency noted during our inspections of November 2005; December 2006, and October 2010.
7. For your revised HACCP plan for Rainbow Trout and Barramundi, at the “Receiving” CCP, we recommend that the column under “Verification” should list “Annual review of QA program and audit results” and “weekly review of monitoring, corrective actions and verification records”. This revised HACCP plan for Rainbow Trout and Barramundi, received with your response, appears to be copied from your HACCP plan for Fresh Mahi Mahi Fillets, Tuna, Amberjack, Blue Fish, Marlin, Shad, and Escolar; therefore, the hazards listed on this plan are not accurate.
Further, 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: Lynn S. Bonner, Compliance Officer at the address noted above. If you have questions regarding any issues in this letter, please contact Compliance Officer Bonner at 215-717-3074 or by e-mail at Lynn.Bonner@fda.hhs.gov.
Anne E. Johnson
Acting District Director
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director