404 BNA Drive Building 200- Suite 500 Nashville, TN 37217 Telephone: (615) 366-7801 FAX: (615) 366-7802
April 10, 2017
WARNING LETTER NO. 2017-NOL-07
UNITED PARCEL SERVICE
Delivery Signature Requested
James R. Shutt, President
Safe Harbour Seafood, Inc.
5822 Heritage Circle
Bon Secour, Alabama 36511-3401
Dear Mr. Shutt:
We inspected your seafood processing facility, located at 5822 Heritage Circle, Bon Secour, Alabama on February 13-16, 2017. We found you have serious violations of the 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 United States Code (USC) 342(a)(4)]. Accordingly, your fishery products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby theymay 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 Internet home page at www.fda.gov.
We acknowledge receipt of your letter, dated February 24, 2017, responding to the FDA 483, Inspectional Observations (FDA 483), issued to you on February 16, 2017. This letter will become part of our official files. Our evaluation of your response is discussed below. Violations revealed during the inspection include, but are not limited to:
1.You must implement the monitoring procedures and frequency which you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures included in your HACCP plans as follows:
A.The monitoring procedures, for each lot of scombrotoxin species fish received, of obtaining harvest vessel records and monitoring the conditions of the fish at the “receiving from harvest vessels” critical control point to control the hazard of “Scombrotoxin formation” listed in your HACCP plan for “Scombrotoxin Species Fish” were not followed.
Specifically, this monitoring procedure was not being followed in that (b)(4) were not being obtained or maintained to show the conditions included in this HACCP plan were being met (such as the time of death for the fish, when/if ice was used to keep the fish at the acceptable temperature, the date and time of off-loading, whether ice was still present on the fish at off-loading, and the internal temperature of the fish at the time of off-loading). In addition, this HACCP plan calls for the (b)(4)and, there were no records available indicating such (b)(4)
Your response provides your planned corrective action to this item and includes a (b)(4) however you have not provided evidence to demonstrate the implementation of this correction (which should include completed forms when this process is implemented). Your response also notes that you have purchased new (b)(4) of the (b)(4) and indicates these(b)(4) will be calibrated on (b)(4). Since your current HACCP plan for scombrotoxin producing fish calls for (b)(4) you should provide clarification and update your HACCP plan to reflect what your (b)(4) schedule will be for your (b)(4) and provide your basis for the (b)(4) schedule.
B.The monitoring procedure, for every lot of shrimp received, of obtaining the (b)(4) that sulfites were not used on the lot at the “receiving” critical control point to control the hazard of “sulfites” listed in your HACCP plan for “Fresh Shrimp” was not followed.
Specifically, this monitoring procedure was not followed in that your firm was not obtaining or maintaining (b)(4) documenting sulfites were not used on the lots of shrimp by the suppliers for lots of shrimp received from (b)(4) through (b)(4)
Your response provided the corrective action of including the statement (b)(4) on future fresh shrimp invoices and to obtain a completed (b)(4) from each supplier of fresh shrimp. You should provide evidence showing the full implementation of this corrective action when fresh shrimp are received.
C.The monitoring procedure, for every lot of fresh whole fish (parasite carriers) sold to secondary processors, of obtaining (b)(4) from the processors at the “Purchasing” critical control point to control the hazard of “Parasites” listed in your HACCP plan for “Fresh Whole Fish (parasite carriers)” was not followed.
Specifically, this monitoring procedure was not followed in that your firm was not obtaining or maintaining (b)(4) for the secondary processors of these fish. As per this HACCP plan, such forms (b)(4)
Your response indicates that you have supplied the (b)(4) to your secondary processers of your fresh whole fish (parasite carriers) and that you have (b)(4). In order to verify this correction we would need to see evidence that your secondary processers have(b)(4)
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
You should respond in writing within 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 harvest vessel records, receiving records, supplier guarantees, parasite fish release forms, 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 your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123), and the Current Good Manufacturing Practice regulation (21 CFR 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 USC 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 non-compliance 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 USC 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 non-compliance 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 U.S. Food and Drug Administration, Attention: David Van Houten, Compliance Officer, 404 BNA Drive, Building 200 – Suite 500, Nashville, TN 37217. If you have questions, concerning the contents of this letter, you may contact Mr. Van Houten at (615) 366-7813.