|Company:||Dairy Farmers of America|
|Subject:||CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated|
|Issuer:||Minneapolis District Office|
|Issued:||Jan. 24, 2011||Closed:||Aug. 10, 2011|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Minneapolis District Office
January 24, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 12
Dairy Farmers of America
10220 North Ambassador Drive
Kansas City, Missouri 64154
Dear Mr. Smith:
The Food and Drug Administration (FDA) conducted an inspection of your Grade B dairy manufacturing facility located at 212 East First Street, Winthrop, Minnesota, from August 16 to September 2,2010. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice regulations for foods, Title 21, Code of Federal Regulations (21 CFR), Part 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations. In addition, FDA investigators performed environmental sampling which identified the presence of Salmonella senftenberg in your facility. Based on FDA's analytical results for the environmental samples and inspectional findings documented during the inspection, we determined that your food products 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 may find the Act and FDA's regulations through links on FDA's home page at www.fda.gov .
During the inspection FDA collected a sample of medium heat, extra grade non-fat dry milk powder, and a total of 106 environmental swabs were taken throughout your processing facility. Laboratory analysis of sample number 638534 confirmed the presence of Salmonella senftenberg in three environmental swabs. These three swabs were taken from (b)(4)
Salmonella senftenberg 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. Healthy individuals may suffer short-term symptoms such as severe diarrhea, bloody diarrhea, fever, chills, abdominal discomfort, and occasionally vomiting.
The inspectors' observations were presented to you on a form FDA-483, Inspectional Observations, at the conclusion of our inspection on September 2, 2010. The most significant noted violations are:
1. Your firm failed to clean and sanitize equipment in a manner that protects against contamination of food and food contact surfaces, 21 CFR 110.35(a).
• Specifically, employees use high pressure spray foamers to clean and sanitize equipment, floors and walls. These foamers may atomize microorganisms which may contaminate food, food contact surfaces and food packaging materials. After cleaning and sanitation has ceased, equipment, floors and walls are air-dried, which results in pools of standing water. Throughout the inspection, standing water was observed in areas where low moisture products are manufactured, including the spray dryer area.
2. Your firm failed to clean and sanitize food contact surfaces of equipment and non-food contact surfaces with sufficient frequency to prevent contamination of food, 21 CFR 110.35(d) and (d)(3).
• Specifically, during our inspection of your facility, extensive product build-up was observed in the spray dryer tote packaging room, including on the tote filling tube.
3. Your employees failed to wash and sanitize hands thoroughly in an adequate hand-washing facility at times when their hands may have become soiled or contaminated, 21 CFR 110.10(b)(3).
• Specifically, on August 16, 2010, in the butter melting room, two employees were observed opening cardboard cases before touching blocks of butter. The employees did not wash or sanitize their hands after opening the cardboard cases.
We acknowledge the corrective actions described in your September 16, 2010, letter responding to the form FDA-483. We also acknowledge receipt of your October 15, 2010, letter regarding corrections to the form 462a, Affidavit. However, the actions you outlined in your responses have not addressed all our concerns. Specifically, you have not provided documentation of your corrections, such as documentation of your implementation of the revised "Pathogen Environmental Monitoring" Program or the modified Sanitation Standard Operating Procedures ("SSOPs"), which are listed in your September 16, 2010, letter.
This letter is not intended to be all-inclusive and may not list all the violations at your facility. You are responsible for ensuring that you manufacture products in compliance with the Act and all of its implementing regulations, including the CGMP regulations (21 CFR 110). You are also responsible for using procedures to prevent further violations of the Act, all applicable regulations, and all other requirements of federal law.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure of your products and/ or enjoining your firm from operating.
You should notify this office in writing within 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. You should include with your response documentation of all corrective actions taken, any training logs, and any other information that would assist us in evaluating your corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your response to Compliance Officer Demetria L. Lueneburg at the address above. If you have questions regarding any issues in this letter, please contact Ms. Lueneburg at (612) 758-7210.
Gerald J. Berg