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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Spence & Co., Ltd. 1/15/13


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
Phone: (781) 587-7500 
FAX: (781) 587-7556 


CMS # 391735
January 15, 2013
Ms. Jean McClain
General Manager
Spence & Co., Ltd.
76 Campanelli Industrial Dr.
Brockton, MA 02301
Dear Ms. McClain:
We inspected your seafood processing facility, located at 76 Campanelli Industrial Dr., Brockton, Massachusetts from November 7, 2012 through November 28, 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). Accordingly, your 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 violation was as follows:
  1. 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."
We have reviewed your revised HACCP plans for cold smoked salmon and gravalox which now list a critical limit at the (b)(4) critical control point (CCP) which are not adequate to control pathogen growth, including Listeria monocytogenes. Specifically, your plans’ CCP for cold salmon and gravalax list the application of a bacteriophage at a critical limit between (b)(4) phages. Although your revised HACCP plans list this new CCP, your firm was not able to provide an adequate validated study to demonstrate the effectiveness of this bacteriophage in controlling Listeria monocytogenes from contaminating your cold smoked fishery products. Your firm has conducted two voluntary recalls of cold smoked fishery products, Wellsley Farms brand 16oz Nova, lot code 6704701, and Spence & Co brand 8oz Smoked Trim, lot code 6704701, on August 22, 2012 andNew York-Style Nova Lox, 4 oz., lot code 9720740, on November 9, 2012, due to positive Listeria monocytogenes contamination in the finished products.
Your firm’s HACCP plans for cold smoked salmon and gravalox also list a critical limit at the (b)(4) that is not adequate to control pathogen growth and toxin formation, including Clostridium botulinum. Specifically, your HACCP plans’ critical limits of (b)(4) and (b)(4) for cold smoked salmon and critical limits of (b)(4) and (b)(4) for gravalax do not ensure that fishery products have been adequately cured to eliminate the specific hazards associated with this CCP. For example, your HACCP plans do not list the amount of salt required for this CL, nor do they list the standardized sizes of cold smoked salmon and gravalax that are to be used for this process. Typically these values are established during the validation study of your curing process.   Such a study would identify the critical factors that are necessary to ensure that the finished product has not less than 3.5% water phase salt in the case of cold smoked salmon and 5% water phase salt in the case of gravalax. These critical limits are required to assure a minimum of 3.5% water phase salt is met when cured with the critical limit listed as “medium salt coverage” to prevent Clostridium botulinum toxin formation. 
We acknowledge receipt of your December 11, 2012 letter in response to the FDA 483 issued at the close of the recent inspection. However, your response does not address these issues.
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 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: Todd Maushart, Compliance Officer, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Compliance Officer Maushart at (781) 587-7500
Mutahar S. Shamsi
District Director
New England District
Cc: Mr. Jonathan Dee, CEO
Alliance Select Foods International, Inc.
Suite 1405, East Tower
Philippine Stock Exchange Centre
Exchange Road
Ortigas Center
Pasig City, Metro Manila, Philippines 1600