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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Portage Prairie Pastured Poultry 23-Feb-07

Department of Health and Human Services' logoDepartment 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


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
2007-DT-0
7


February 23, 2007

Mr. John House, Coop Manager
Portage Prairie Pastured Poultry
3305 Buffalo Road
Niles, Michigan 49102

Dear Mr. House:

A joint investigation by the U.S. Food and Drug Administration and the Michigan Department ,of Agriculture, on October 26, 2006, has documented violations of the Public Health Service Act (PHS Act) and a Federal regulation promulgated under the PHS Act.

Our investigation determined that your firm transports and further distributes unpasteurized raw milk and cream in interstate commerce, in finished form for human consumption. Such distribution is a violation of the PHS Act, 42 U.S.C. § 271(a), and the regulations codified,in Title 21, Code of Federal Regulations (CFR), section 1240.61(a). The regulation prohibits the delivery into interstate commerce of milk and milk products in final package form for direct human consumption unless they have been pasteurized. The unpasteurized milk and cream you pick up in [redacted] and transport to your farm in Michigan for distribution to your Co-op members, are in final package form for direct human consumption. For your information, we have enclosed a copy of the regulation as it was published in the Federal Register, 52 FR 29,509. (Aug 10, 1987).

The above observation is not intended to be an all-inclusive list of violations. It is your responsibility to ensure adherence with all requirements of the PHS Act and implementing regulations. You should take prompt action to correct this deviation and prevent any future recurrence. Failure to make prompt corrections could result in regulatory action without further notice.

Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions can not be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.

Your response should be sent to the Food and Drug Administration, Attention: Judith A. Jankowski, Detroit District Office, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issues in this letter, please contact Judith A. Jankowski at 313-393-8125.

Sincerely,
/S/

Joann M. Givens
District Director
Detroit District Office
Enclosure