Inspections, Compliance, Enforcement, and Criminal Investigations
Rockland Farm 3/26/07
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
|New England District |
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
March 26, 2007
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Leonard M. Giglio, Owner
50 South Road
Bolton, Connecticut 06043
Dear Mr. Giglio:
An inspection of your dairy farm operation located at 50 South Road, Bolton, Connecticut, conducted by representatives of the U.S. Food and Drug Administration (FDA) on January 9, 11, 18, and 31, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated under 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 drug, gentamicin sulfate, to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] and unsafe under section 512 [21 U.S.C. § 360b] of the Act.
You can find the Act and its associated regulations o the Internet through the links on the FDA web page at www.fda.gov.
On or about October 23, 2006, you offered for sale an adult dairy cow identified, with farm tag # 14 and back tag # 16CR3706, for slaughter as food to [redacted]. The animal was then sold to [redacted] and transported to that firm where it was slaughtered for human food on October 24, 2006. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of gentamicin in the kidney tissue of this adult dairy cow. No tolerance has been established for residue of gentamicin in the uncooked edible tissues of cattle. The presence of this drug in the uncooked edible tissues from this animal 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 animal under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, our Investigators noted the following conditions on your dairy farm:
1. You lack an adequate record keeping system for determining the medication status of animals you offer for slaughter.
2. You lack an adequate record system for assuring that animals, to which you administer medication, have been withheld from slaughter for appropriate periods of time to deplete potentially hazardous residues of drugs from edible tissues.
Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Act.
In addition, you adulterated gentamicin sulfate within he 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 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) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. 530. Our investigation found that your extralabel use of gentamicin sulfate failed to comply with these requirements.
For example, you administered the gentamicin sulfate in an animal class or species it is not approved for 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 a residue which may present a risk to public health, in violation of 21 C.F.R. 530.11(c). Because your extralabel use of this drug was not in compliance with 21 C.F.R. 530, the drug was unsafe under section 512(a)(5) [21 U.S.C. § 360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [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 food you distribute is 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 (15) 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 written response should be sent to Bruce R. Ota, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, 4th floor, Stoneham, MA 02108.
Gail T. Costello
New England District