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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gutman Brothers, LTD 10/15/12

  

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

Public Health Service
Food and Drug Administration
 

PHILADELPHIA DISTRICT

900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390

WARNING LETTER
13-PHI-02

October 15, 2012

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
/or/ United Parcel Service
 

Mr. Abraham Gutman, President/Partner
Gutman Brothers·, Ltd.
6311 Greenspring Avenue
Baltimore, Maryland 21209-2301
 

Dear Mr. Gutman:
 

On August 8, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 321 Rancks Church Road, New Holland, Pennsylvania 17557. 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 two 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, our investigation at on or about March 26, 2012, you sold a bob veal calf, identified with back tag#(b)(4) for slaughter as food. On or about March 27, 2012, (b)(4) slaughtered this animal. United States Department of Agriculture, Food and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal on March 27, 2012, identified the presence of 25.715 parts per million (ppm) of sulfamethazine residue in the liver and 18.979 ppm in the muscle tissue. Our investigation also revealed that on or about April 2, 2012, you sold a bob veal calf, identified with back tag#(b)(4) for slaughter as food. On or about April 3, 2012, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal on April 3, 2012, identified the presence of 21.797 parts per million (ppm) of sulfamethazine residue in the liver and 21.733 ppm in the muscle tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.670 (21 C.F.R. 556.670). However, FDA has not established a tolerance for the use of Sustain III Calf Bolus (sulfamethazine sustained-release boluses, NADA #120-615) in the edible tissue of calves less than one month of age or in calves being fed an all milk diet as codified in 21 C.F.R. 520.2260b. The presence of this drug in edible tissue from these animals in these amounts 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 drug Sustain III Calf Bolus (sulfamethazine sustained-release boluses, NADA #120-615). Specifically, our investigation revealed that you did not use Sustain III Calf Bolus as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra label 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 Sustain Ill Calf Bolus (sulfamethazine sustained-release boluses, NADA #120-615) to two separate bob veal calves identified with back tags (b)(4) & (b)(4) without following the animal class as stated on the approved labeling. Your extralabel use of Sustain III Calf Bolus was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use of Sustain III Calf Bolus resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11 (c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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 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.

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 Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, Room 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Compliance Officer Robin M. Rivers at (215) 717-3076 or Email at robin.rivers@fda.hhs.gov.
 

Sincerely yours,
/S/
Kirk D. Sooter
District Director
Philadelphia District
 


cc: Mr. Daniel E. Gutman, Partner
Gutman Brothers, Ltd.
6311 Greenspring A venue
Baltimore, Maryland 21209-2301
 

Mr. Benjamin Z. Gutman, Partner
Gutman Brothers, Ltd.
6311 Greenspring A venue
Baltimore, Maryland 21209-2301
 

Mr. David Gutman, Partner
Gutman Brothers, Ltd.
6311 Greenspring A venue
Baltimore, Maryland 21209-2301
 

Dr. Isabel Arrington, Director T A/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Office of Policy and Program Development
1616 Capitol Avenue, Suite 260
Omaha, NE 68102
 

Dr. David R. Griswold, Acting Director
Pennsylvania Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BARDS)
2301 North Cameron Street
Harrisburg, Pennsylvania 17120
 

Mr. Thomas Alexander
Chief of Regulation and Compliance
Pennsylvania Department of Agriculture
Bureau of Animal Health
Room 408
2301 North Cameron Street
Harrisburg, Pennsylvania 17110