Inspections, Compliance, Enforcement, and Criminal Investigations
Greencore OARS, LLC 12/28/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
UNITED PARCEL SERVICE
December 28, 2011
Mr. Liam McClennon
Chief Executive Officer
Greencore OARS, 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 121 Liberty Street, Brockton, MA 02301 between February 28, 2011 and March 17, 2011 and again on September 27, 2011 – September 30, 2011, October 11, 2011, October 17, 2011 and October 20, 2011. During the February/March 2011 inspection, environmental swabs were collected from your processing facility. During the September/October 2011 inspection, finished ready-to-eat (RTE) tuna fish sandwich product and environmental swabs samples were collected from your processing facility. The analyses of environmental swabs and finished product samples revealed the presence of Listeria monocytogenes (L. monocytogenes).
The presence of the human pathogen Listeria monocytogenes in a sample of your finished product causes the food to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)], in that the sandwich contained a poisonous or deleterious substance which may render it injurious to health. 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. We acknowledge that the products associated with the positive L. monocytogenes finding were voluntarily destroyed. However, numerous strains of L. monocytogenes were detected in your plant environment and the presence of L. monocytogenes in your ready to eat finished product indicates that cross contamination likely occurred from contact with processing room surfaces. 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.
We also 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 (21 CFR 123), and the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 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 refrigerated tuna fish sandwiches 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 and food regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA's home page at www.fda.gov.
We have reviewed your firm’s response of October 25, 2011 and note that it lacks sufficient corrective actions. We also find that your corrective actions concentrate only on the tuna fish manufacturing process. We recommend you perform a comprehensive assessment of your entire manufacturing operations of all products and processes to determine the root cause of the positive Listeria monocytogenes findings.
Specific violations observed during the inspections include, but are not limited to, the following:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). Your firm did not monitor the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces or protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency to ensure compliance with the CGMP requirements in 21 CFR 110 as evidenced by:
a. Pooling water was observed on the floor in the production room.
b. Condensate was observed above the tuna sandwich processing lines (b)(4).
We acknowledge receipt of your response dated October 25, 2011. Your response is unacceptable because it does not address or provide a corrective action to the root cause of these deficiencies. There is no assurance that your proposed correction will prevent re-occurrence. FDA recommends that your sanitation controls include effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L. monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination.
Current Good Manufacturing Practice (cGMP)
1. You must manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2). However, during the inspections, FDA collected environmental samples from your sandwich processing rooms and a finished product sample that identified the presence of Listeria monocytogenes .
We acknowledge receipt of your response dated October 25, 2011, and have reviewed your response. We understand that after these findings, intensified cleaning and sanitizing operations and testing were conducted. However, you were cited for similar observations in the past FDA inspection and promised similar corrective actions, which demonstrates your proposed corrections are not addressing the problem on a permanent basis. Your response does not include details of how you will reassess your current Listeria monitoring program. Strict in-plant sanitation measures must be instituted to eliminate the organism or prevent the proliferation in the plant. FDA recommends that you outline the steps you will take if swabbing or sample results reveal potential contamination in your facility or in your product, and when these results should prompt intensified cleaning and sanitizing operations and further testing.
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, 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: Lori A. Holmquist, Compliance Officer, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8268 x 13.
Mutahar S. Shamsi
New England District Office
Cc: Mr. Richard Donovan
Greencore OARS, LLC
121 Liberty Street
Brockton, MA 02301
Mr. Patrick Coveney
Chief Executive Officer
Greencore Group PLC
Northwood Business Park
2 Northwood Avenue
Santry, Dublin 9, Ireland