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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Rainbow Acres Farm 4/20/10

   

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

 Public Health Service
Food and Drug Administration
  PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390

WARNING LETTER


10-PHI-07


DELIVERED VIA UPS


April 20, 2010


Mr. Daniel L. Allgyer, Owner
Rainbow Acres Farm
26 S. Kinzer Road
Kinzers, PA 17535


Dear Mr. Allgyer:


An investigation by the U.S. Food and Drug Administration has determined that you are causing to be delivered into interstate commerce, selling, or otherwise distributing raw milk in final package form for human consumption. Such distribution is a violation of the Public Health Service (PHS) Act, Title 42 United States Code, Section 264(a), and the implementing regulation 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. For your information, we have enclosed a copy of the regulation as it was published in the Federal Register, 52 FR 29509 (Aug 10, 1987).


This letter is not intended to provide an all-inclusive list of violations. It is your responsibility to ensure adherence with all requirements of the PHS Act, Federal Food, Drug, and Cosmetic Act, and implementing regulations. For instance, you should ensure that your products are properly labeled. You should take prompt action to correct the above deviation and prevent any future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.


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 cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.

Your reply should be directed to Richard C. Cherry, Compliance Officer, at the above letterhead address. If you have any questions with regard to this letter, he can be reached at 215-717-3075 or Richard.Cheny@FDA.HHS.GOV.


Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District


cc: (b)(4)
delivered via fax


Pennsylvania State Department of Health
132 Kline Plaza, Suite A
Harrisburg, PA 17104

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