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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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H&H Feed & Grain, Inc. 20-Aug-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  Detroit District
300 River Place
Suitee 5600
Detroit, MI 48207
Telephone: 313-383-8100
FAX: 313-393-8139


Certified Mail

Return Receipt requested

Warning Letter

2003-DT-20

August 20, 2003

Mr. Patrick M. Hunter, President
H&H Feed & Grain, Inc.
14096 Portege Road
Vicksburg, Michigan 48007

Dear Mr. Hunter:

An investigation of your feed mill located at 14096 Portage Road, Vicksburg, Michigan, conducted by a Food and Drug Administretion (FDA) investigatar on February 6 and 14, 2003, found significant deviations from the mquirementa relating to animal drugs and medicated feeds, inctudfng the Veterinary Feed Directive (VFD) regulations (Title 21, Code of Federal Regulations, section 556.6). Such deviations caused an animal drug to be adulterated under Section 501 (a)(5) of the Federal Food, Drug, and
Cosmetic Act (the Act) and misbranded under Section 504(a)(5) ‘of the Act. The deviations also caused animal feed to be adulterated under Section 501 (a)(6) of the Act and misbranded under Section 604(b) of the Act.

Our investigation found your feed mill to be manufacturing complete medicated swine feeds containing the Veterinary Feed Directive (VFD) drug Tilmicosin in a manner that does not conform to the requirements of the Act and the agency’s regulations.
The deviations include:

(1) Your feed mill failed to use the Type E medicated feed containing Tumicosin in accordance with labeled mixing directions, which resulted in sub-potent feeds. This caused it to be unsafe under Section 512(a) of ths Act and adulterated within the meaning of Section 501(a)(6) of the Act.

(2) Your feed mill failed to follow the product’s conditions of use by not feeding continuously for a 21 day period. This caused the drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act.

(3) Your feed mill manufactured Type C medicated feed containing Tilmicosin that failed to contain labeling conforming to the animal drug’s approval.

For example, it did not contain ingredient statements, cautionary statements, or withdrawal information. This caused the medicated feed to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501 (a)(6) of the Act.

(4) The VFD medicated feed labeling did not contain the cautionary statement: Caution: Federal law limits this dnrg to use under the professional supervision of a of a licensed veterinarian. Animal feed beating or containing this veterinary feed directive drug shall be fed to animils only by or upon a lawful veteranary feed directive issued by a licensed veterinarian in the course of the veterinarian's
professional practice. 21 CFR 558.6(f) requires all labeling and advertising of VFD drugs and animal feeds containing VFD druga to prominently and conspicuously diapiay this statement. Your failure to do so caused the animal feed to be misbranded within the meaning of Section 504(b) of the Act.

(5) Your firm manufactured, in June, October, and November of 2002, for its own use and for distribution, at least [redacted] batches of VFD feeds containing Tiimicosin when no VFD was in effect. Also, in October of 2002 and February of 2003, you manufactured complete feeds not covered by a complete and valid VFD. For example, some VFD on file at your firm lacked the statement required in 21 CFR 558.6 (a)(4)(xii), Extra-label use (i.e., use of this VFD tied in a manner other than as provided for in the VFD drug approval) is strictly prohibited. Failure to follow the VFD requirements caused the me4icated feed to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501 (a)(6) of the Act.

(6) Your firm has been distributing feeds containing a VFD drug since early 2002, but has not submitted a notification letter to FDA’s Center for Veterinary Medicine that you intend to distribute animal feed ccnteining a VFD drug as required by 21 CFR 5586(d). This causes the drug to be misbranded within the meaning of Section 504(a)(3)(C) of the Act.

The above is not intended as an ail-inclusive list of violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for ensuring that you are in complianca with the law. You ahoutd take prompt action to cormot these violations, and
you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory acion without further natice, such as seizure and/or injunction.

You should notify this office, in writing, within fifteen (15) working clays of receiving this letter of ths steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step bsing taken to correct the
violations and prevent their nxxrrence, If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections till bo completed. Include copies of any available documentation demonstrating that
corrections have besn made.

Your response should be directed to Mr. David M. Kaszubski, Director Compliance Branch, at the address above.

Sincerely yours,

/s/

Joann M. Givens

District Director

Detroit District Office