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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Greencore USA, LLC 10/17/12


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
(781) 587-7500
FAX: (781) 587-7556


CMS #318898


Date 10/17/2012

Mr. Liam McClennon
Chief Executive Officer
Greencore USA, LLC
12 Kent Way
Byfield, MA 01922

Dear Mr. McClennon:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) sandwich manufacturing facility located at 2 Opportunity Way, Newburyport, MA 01950 between June 4, 2012 and June 12, 2012. On June 4, 2012, FDA collected environmental samples from multiple areas in your processing facility. FDA laboratory analyses of the environmental swabs (FDA sample number 747945) found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including on food contact surfaces where seafood sandwiches are prepared. In addition, FDA investigators observed a serious violation of the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110], and seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 [21 CFR Part 123]. Based on this violation and our findings L. monocytogenes in your processing facility, we have determined that your ready-to-eat seafood sandwiches are 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act, the CGMP regulation for foods, and the seafood HACCP regulation through links in FDA's home page at www.fda.gov.

Listeria monocytogenes is a pathogenic bacterium that can contaminate foods, resulting in a mild illness called listerial gastroenteritis or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals, the elderly, and unborn fetuses are particularly susceptible to listeriosis. Listeria monocytogenes differs from most other foodborne pathogens because it is widely distributed, resistant to diverse environmental conditions, and  grows under refrigeration conditions. It is essential that you identify all areas of your facility where L. monocytogenes is able to grow and survive (niche areas) and take such corrective actions as necessary to control the organism.

Laboratory analyses confirmed the presence of L. monocytogenes in environmental sub sample (Sub) ((b)(4) a conveyor belt on a sandwich production line), Sub (b)(4) (the underside of a metal jacket which is part of a sandwich production line), and Sub (b)(4) (a production table where sandwiches are processed).

In addition, you must clean equipment and food contact surfaces in a manner that protects against contamination of food, as required by 21 CFR 110.35(a) and (d) and 21 CFR 123.11(b). However, your firm did not adequately clean food contact surfaces, as demonstrated by the (b)(4) environmental sub samples from food contact surfaces in your sandwich processing room which confirmed the presence of Listeria monocytogenes.

FDA also found the presence of Listeria monocytogenes in environmental samples taken in your facility during an inspection FDA conducted in (b)(4) . As a result of that inspection, you and management representatives of your firm attended a regulatory meeting at the FDA New England District Office on (b)(4). At this meeting, you stated your commitment to correct the conditions and practices that led to the Listeria monocytogenes findings discovered during the January 2011 inspection; the corrections included (b)(4).

We acknowledge receipt of your response, dated June 16, 2012, and have reviewed the response. We understand that after these findings, production was ceased and products manufactured within the affected sandwich processing area were held out of commerce. We also understand (b)(4) were conducted in the affected area. Your response includes details on how you will reassess your current Listeria monitoring program. Your procedure, SOP QA04.07, outlines the steps you will take to monitor all of your ready-to eat manufacturing areas including your (b)(4) corrective actions to be taken if (b)(4) reveal potential contamination in your facility or in your raw or finished products. Your procedure, SOP QA04.07 A, references your (b)(4). Your procedure, SOP QP04.39, outlines the additional frequency of (b)(4) that must be conducted for (b)(4) as well as the (b)(4) to be utilized. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility. Please notify the FDA of any positive Listeria monocytogenes samples.

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. 

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, any modifications to your cleaning and sanitation standard operating procedures, steps taken to monitor and control Listeria contamination in your facility, 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.

Section 743 (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs form 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 reinspection-related costs.

Please send your reply to the Food and Drug Administration, Attention: Anthony P. Costello, Compliance Officer, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Costello at 781-587-7492.



Mutahar S. Shamsi
District Director
New England District