Thumb Oilseed Producers' Cooperative 6/24/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

WARNING LETTER
2010-DT-15

June 24, 2010

VIA UPS

Joann F. Rutkowski
Chief Operating Officer
Thumb Oilseed Producers' Cooperative
2145 Leppek Road
Ubly, MI 48475-9790

Dear Ms. Rutkowski:

The Food and Drug Administration (FDA) conducted an inspection of your soy grit and soy flour manufacturing facility located at 2145 Leppek Road, Ubly, MI, from January 28 through February 23, 2010. During the inspection, FDA collected environmental samples from various locations within your processing facility, as well as finished product samples. FDA laboratory analyses of the environmental samples (FDA sample numbers 584663, 584664 and 584665) found Salmonella in forty-three (43) areas within your manufacturing plant. Each of these positive subsamples was further serotyped and determined to be Salmonella senftenberg (s. senftenberg), with an indistinguishable Pulse-Field Gel Electrophoresis (PFGE) pattern. The discovery of an indistinguishable S. senftenberg serotype pattern from multiple locations within your manufacturing facility indicates that Salmonella may have become established in a niche environment in your facility. Further, FDA's finding of an indistinguishable PFGE pattern among isolates obtained from environmental swabs (collected from non-food contact surfaces, including a forklift wheel and gap in the processing floor) with a sample of finished product organic soy flour collected at your facility (FDA sample number 519231) is significant because it demonstrates the potential for Salmonella contamination in finished product.

Based on FDA's analytical results for environmental samples and inspectional findings documented during the inspection, we determined that your firm's soy grit and soy flour products were 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 and its associated regulations on the internet through links on the FDA webpage at www.fda.gov.

As noted above, during the inspection, FDA also collected finished product samples, including a sample of "Organic Low - Fat Soy Flour" (FDA sample number 519231) manufactured at your facility. Our analysis of the soy flour revealed the product to be contaminated with S. senftenberg. Salmonella, including the S. senftenberg serotype, is a microorganism that is known to be pathogenic to humans. FDA's laboratory confirmation of S. senftenberg in your finished product soy flour causes the lot to be adulterated within the meaning of Section 402(a)(1) of the Act [21 U.S.C. 342(a)(1)], in that it bears or contains a poisonous or deleterious substance which may render the product injurious to health. FDA acknowledges that your firm initiated a voluntary recall of these soy products on February 25, 2010.

Appropriate control of Salmonella in a food processing environment requires expert knowledge of the unique characteristics of the organism. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.

Further, serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110), including violations that created possible routes of cross-contamination, were identified by our investigators and documented in the Form FDA-483, lnspectional Observations, issued to you, on February 23, 2010. We have reviewed your March 2, 2010, March 24, 2010, and April 8, 2010, response letters and have determined that additional information is needed in order to assess the adequacy of your completed and planned corrective actions. For example, your responses identify a number of planned corrections, including "working" with a third-party to decontaminate your facility, developing an "environmental control plan," and establishing various "cleaning procedures and/or Sop's" for decontaminating processing areas and equipment. However, your response letters do not include the details of your (1) decontamination plan, including the methods and sanitizing agents to be utilized, (2) ongoing environmental monitoring plan, and (3) revised sanitation standard operating procedures (SSOPs). In addition, your response letter should include information about your corrective action plan for addressing potential positive Salmonella findings in the future. Please submit copies of records to
support your planned and taken corrective actions.

This letter may not list all of the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and FDA regulations, including the CGMP regulation for foods. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.

We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions, including any further specific steps that you have taken to correct the noted violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
 

Please send your reply to the Food and Drug Administration, Attention: Mr. Steven B. Barber, Director of Compliance, Detroit District Office, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issues in this letter, please contact Mr. Barber at 313-393-8110.

Sincerely,

/S/

Joann M. Givens
District Director
Detroit District Office
 

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