| Public Health Service Food and Drug Administration |
| New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 587-7500 FAX: (781) 587-7556 |
Department of Health and Human ServicesNWE-26-11W
VIA UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
August 11, 2011
Michael P. Ferry, Owner
Michael P. Ferry, Inc.
641 Gifford Road
Westport, Massachusetts 02790
Dear Mr. Michael P. Ferry:
On May 24, 26, and June 2, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 729 Gifford Road, Westport, Massachusetts 02790. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, as referenced in the table below, our investigation revealed that on or about the dates listed in the table below you sold three bob veal calves for slaughter as food that were subsequently slaughtered by (b)(4). As described in the table below, the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS), analysis of tissue samples collected from these three animals identified the presence of drugs in the edible tissues in which illegal residues were reported.
Sample Number | Date Sold | Slaughter Date | Identification | Animal Tissue | Residue | Residue Level (ppm) |
576161 | 01/11/2011 | 01/13/2011 | (b)(4) | Kidney | Neomycin* | (b)(4) |
576765 | 11/04/2010 | 11/04/2010 | (b)(4) | Kidney | Gentamicin** | Detected |
576554 | 07/20/2010 | 07/21/2010 | (b)(4) | Kidney | Neomycin* | (b)(4) |
* FDA has established a tolerance of 7.2 parts per million (ppm) for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of (b)(4) (Medicated) containing oxytetracycline and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) (Medicated) containing oxytetracycline and neomycin in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
** FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle. The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
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. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drugs neomycin and oxytetracycline that were contained in the (b)(4) (Medicated), (b)(4) (penicillin G procaine) Injectable Suspension, (b)(4), and (b)(4) Injectable Solution, (b)(4). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use, 21 C.F.R. 530.3(a). We have enclosed a copy for your reference.
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered the new animal drugs neomycin and oxytetracycline that were contained in the (b)(4) (Medicated) to your bob veal calves without following the animal class as stated in the approved labeling. Your extralabel use of the new animal drugs neomycin and oxytetracycline that were contained in the (b)(4) (Medicated) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs in the (b)(4) (Medicated) was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
The investigation also found that you administered the following new animal drugs contrary to the conditions of use set forth in their approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a):
- (b)(4) (Penicillin G procaine) Injectable Suspension, (b)(4) – You administered this product to lactating dairy cows without following the approved indications for use, dosage amount, route of administration, or dosage amount per injection site. (b)(4) (Penicillin G procaine) Injectable Suspension, (b)(4), is not indicated for treating mastitis in cattle, not approved at a dose more than (b)(4) pounds of body weight, not to be administered intraveneously, and not approved for use at the rate of more than (b)(4) per injection site.
- (b)(4) Injectable Solution, (b)(4) – You administered this product to lactating dairy cows without following the approved animal class. (b)(4) Injectable Solution, (b)(4), is not approved for use in female dairy cattle (b)(4) of age or older.
In addition, you adulterated the animal feed, (b)(4) (Medicated), within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use this medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
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 violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. The Massachusetts Department of Agricultural Resources will be advised of the issuance of this Warning Letter.
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 corrective action cannot be completed within fifteen (15) working days of receiving this letter, 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 Lori A. Holmquist, Compliance Officer, U.S. Food and Drug Administration, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have any questions about this letter, please contact Compliance Officer Lori A. Holmquist at 207.622.8268 x 13.
Sincerely yours,
/S/
Mutahar S. Shamsi
District Director
New England District
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