CERTIFIED MAIL RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-12-46

September 12, 2012
 

Brendan J. Maher (Owner)
St. James Smokehouse Inc.
3109 Grand A venue #216
Miami, Florida 33133-5103
 

Dear Mr. Maher:

We inspected your seafood processing facility, located at 3555 NW 77 Ave. Miami, FL 33122 from May 13 to June 8, 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, 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).

As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).

Accordingly, your vacuum packed cold smoked salmon products 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.

Your significant violations were as follows:

1. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedure of "temperature data logger during transit" at the critical control point of "Receive Delivery" to control for pathogen growth and toxin formation listed in your HACCP plan for cold smoked salmon.

For example, the following vacuum packed cold smoked salmon shipments received from St. James Smokehouse, Scotland identified below were received without temperature records.
 

• Entry (b)(4) received on 4/12/2012
• Entry (b)(4) received on 4/13/2012
• Entry (b)(4) received on 4/12/2012
 

In addition, you are not following your monitoring procedures of "temperature data logger" at the critical control point of "Transfer to Chilled Storage" to control for pathogen growth and toxin formation listed in your HACCP plan for cold smoked salmon.

For example, your firm does not have temperature records for vacuum packed cold storage salmon received from St. James Smokehouse, Scotland on 4/12/2012 under Entry (b)(4)

Furthermore, you are not following your verification procedures of "Weekly calibration of temperature probes" at the critical control point "Receive Delivery" to control for pathogen growth and toxin formation listed in your HACCP plan for cold smoked salmon.

For example, your calibration records show your probes were last calibrated on 3/28/2012.

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 Part 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 cold smoked salmon lists a critical limit of "Internal temperature of delivery no greater than 38° F" and Presence of Ice" at the critical control point of "Receive Delivery" is not adequate to control pathogenic bacteria growth and toxin formation.

3. You must have a HACCP plan that, at a minimum lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for cold smoked salmon lists a monitoring procedure/frequency at the critical control point "Receive Delivery" is not adequate to control pathogen growth and toxin formation.

4. You must implement an affirmative step which ensures that fish and fishery products you import are processed in accordance with the seafood HACCP regulation 21 CFR 123.12(a)(2)(ii). However, your firm performed an affirmative step of having a copy of the foreign HACCP plan for imported vacuum packed aqua cultured smoked salmon from St. James Smokehouse LTD., Scotland (U.K.) in English that was not adequate. Your foreign firm's HACCP plan does not identify hazards at any of the critical control points.

In addition, your firm failed to have on file a letter of Guarantee from (b)(4), Scotland as part of your affirmative step for the fresh whole salmon products that you imported from Scotland on 5/2/2012 under U.S. Customs entry (b)(4).

We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.

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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.

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. Are-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)). 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: Mizanne E. Lewis, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Mrs. Lewis at 407-475-4731.
 

Sincerely,
/S/

Emma R. Singleton
Director, Florida District