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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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E.A. Sween Company 08-Aug-05

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

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7115
FAX: (612) 334-4142


August 8, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN-05-18

Thomas E. Sween
Chairman/ CEO
E. A. Sween Company,
16101 78th Street West
Eden Prairie, MN 55344

Dear Mr. Sween:

The Food and Drug Administration (FDA) conducted an inspection of your facility, E. A. Sween Company, located at 16101 78th Street West, Eden Prairie, Minnesota, on March 7-11, 14-15, 17-18, 23, 30-31 and April 1, 4-5, and 7-8, 2005, as a follow-up to findings by the Florida Department of Agriculture and Consumer Services (FDACS) of of Listeria monocytogenes (L.mono) in your Deii Express Turkey and Cheese Sandwiches, lot #450191. L. mono is a pathogenic organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, or diarrhea, L. mono infections can cause miscarriages or stillbirths among pregnant women.

During the FDA inspection, investigators collected samples from various processing areas in your facility. Microbiological analysis detected the presence of L. mono in two environmental samples, FDA samples #308904 and #308905. Sample #308904 was collected on March 10, 2005, from the underside and the surrounding food contact surfaces of the conveyor belt used to transport meat from your [redacted] meat slicer. Sample #308905 was collected on March 17, 2005, from a non-food contact surface on the support beam areas of your [redacted] cheese slicer.

FDA conducted pulsed-field gel electrophoresis (PFGE) analyses on the L. mono samples to compare the DNA profiles of the isolates obtained from environmental samples collected from your facility, and from finished product sandwich samples manufactured by your firm, which were all found to be contaminated with L. mono. Analyses revealed that the isolates obtained from two FDA environmental samples (#308904 and #308905) collected one week apart, March 10 and 17, 2005, shared the same PFGE pattern. In addition, the isolates obtained from these environmental samples matched the PFGE pattern of isolates obtained from two finished product samples (turkey and cheese sandwiches) collected by FDACS on February 16, and March 4, 2005. The implicated finished product sandwich samples collected by FDACS were manufactured at your facility on January 19, 2005, and February 15, 2005, respectively.

The presence of the same strain of L. rnono in environmental samples collected from the food processing areas in your facility, including food contact surfaces, and in finished product samples causes your ready-to-eat sandwich products to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act), in that the sandwiches were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.

Neither this letter nor the Form FDA-483, Inspectional Observations, issued at the conclusion of the inspection is meant to be an all-inclusive list of deficiencies that may exist at your facility. It is your responsibility as top management to ensure that your establishment is in compliance with all requirements of the Federal regulations.

You should notify this office in writing within fifteen (15) working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure, injunction and prosecution. Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.

Sincerely,

/S/


W. Charles Becoat
Director
Minneapolis District