Inspections, Compliance, Enforcement, and Criminal Investigations
Forest Grove Dairy 08-Feb-07
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, M1 48207
RETURN RECEIPT REOUESTED
February 8, 2007
Mr. David J. Hochstetler, Owner
Forest Grove Dairy
59023 County Road #43
Middlebury, Indiana 46540
Dear Mr. Hochstetler:
A joint investigation by the U.S. Food and Drug Administration, the Indiana Board of Animal Health, and the Michigan Department of Agriculture, 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 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 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. The milk and cream you produce in Indiana and distribute to Cooperatives in Michigan and Illinois for further distribution to their Co-op members is 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.
In addition to the violation above, we have several comments concerning the lack of labeling of your raw milk and cream products. First, we note that your raw milk and cream products do not contain labeling that specifies the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). We also note that your raw milk and cream products do not contain a principal display panel bearing a declaration of the net quantity of contents (21 CFR 101.105). Lastly, we note that your raw milk and cream products fail to have labels that declare their ingredients (21 CFR 101.4).
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 directed to Judith A. Jankowski, Compliance Officer, at the above letterhead address. If you have any questions regarding any issues in this letter,please contact Ms. Jankowski at 313-393-8125.
Joann M. Givens
Detroit District Office