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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Stonyvale Inc. 06-Mar-06

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

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, MA 02180
(781) 596-7700
FAX: (781) 596-7896



WARNING LETTER
NWE-09-06W

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

March 6, 2006

Robert Fogler, President
Stonyvale, Inc.
226 Fogler Road
Exeter, Maine 04435

Dear Mr. Fogler:

An investigation of your dairy farm operation located et 226 Fogler Road, Exeter, Maine, 04435, conducted by a representative of the U.S. Food and Drug Administration (FDA) on November 22, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated within the meaning of sections 402(a)(2)(C)(ii) [21 U.S.C.§ 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drugs, sulfadimethoxine, oxytetracycline, and amoxicillin, to become unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through the links on the FDA web page at www.fda.gov.

On or about September 27, 2005, you offered for sale an adult dairy cow identified with backtag # 11 EJ9346, ear tag # 11 VAW8368, and farm tag # 2795, for slaughter as food at [redacted]. On or about September 28, 2005, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis (Laboratory Report number 467388) of tissue samples collected from that animal identified the presence of 3.80 parts per million-(ppm) sulfadimethoxine in liver tissue and 3.63 pprn of sulfadimethoxine in muscle tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations C.F.R, Section 556.640 (21 C.F.R. 556.640). The presence of this drug in the edible tissues of this animal in an amount above the established tolerance causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) (21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Your record system lacks adequate controls to ensure that animals medicated by you, but not intended for human consumption, are not introduced into the food supply. For example, the appropriate period of time to permit depletion of potentially hazardous drug residues from edible tissues was not met for a culled cow intended for destruction. However, instead of being destroyed, this cow was sent to a slaughterhouse. The lack of adequate controls resulted in the cow being slaughtered for meat. Food from animals held under such conditions is adulterated under section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.

In addition, you adulterated sulfadimethoxine, oxytetracycline, and amoxicillin within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must. comply with sections 512(a)(4) and 512(a)(5) [21 U.S.C. §.360b(a)(4) and 21 U.S.C. § 360(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigator found that your extralabel use of sulfadimethoxine, oxytetracycline, and amoxicillin failed to comply with these requirements.

For example, you administered sulfadimethoxine, oxytetracycline, and amoxicillin without following the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore; your extralabel use resulted in an illegal drug residue of sulfadimethoxine, in violation of 21 C.F.R. 530.11(d). In addition, you used sulfadimethoxine in an extralabel fashion when you used this drug to treat mastitis. The extralabel use of sulfadimethoxine in lactating dairy cows is prohibited by 21 C.F.R. 530.41(g). Because your extralabel use of these drugs were not In compliance with 21 C.F.R. Part 530, your use caused the drugs to be unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and adulterated within the meaning of section 501(ax5) [21 U.S.C. § 351 (a)(5)] of the Act.

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the foods you distribute are in compliance with the law.

You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has, been taken or will be taken to correct the violations and prevent their recurrence. If the corrective action cannot be completed within fifteen (i5) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your response should be sent to Ann Simoneau, Compliance Officer, U.S. Food and Drug Administration, One Main Street, 4th floor, Stoneham, MA 02108.

Sincerely,

/S/

Gail T. Costello
District Director
New England District Office