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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Levi M. Lapp 6/14/13

  

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-21
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
June 14, 2013
 
 
Mr. Levi M. Lapp, Owner
1736 Beaver Valley Pike
Strasburg, Pennsylvania 17579-9749
 
Dear Mr. Lapp:
 
On May 6 and 8, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1736 Beaver Valley Pike, Strasburg, Pennsylvania. 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 an animal for slaughter as food that was 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 revealed that on or about February 18, 2013, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about February 20, 2013, (b)(4), located at (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfamethazine in the muscle at 25.35 parts per million (ppm) and 25.1 ppm in the liver. 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, this tolerance does not apply to the use of Sustain III Calf Bolus (sulfamethazine), NADA 120-615, in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of Sustain III Calf Bolus (sulfamethazine), NADA 120-615, in veal calves (pre-ruminating calves). The presence of this drug in edible tissues from this animal 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 in 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), NADA 120-615. Specifically, our investigation revealed that you did not use Sustain III Calf Bolus (sulfamethazine), NADA 120-615, as directed by its approved labeling. Use of this drug in this manner is an extralabel use as defined under 21 C.F.R. 530.3(a).  A copy of 21 C.F.R. Part 530 is attached 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 Sustain III Calf Bolus (sulfamethazine), NADA 120-615, to your bob veal calf, identified with back tag (b)(4), without following the animal class as stated on the approved labeling. Your extralabel use of Sustain III Calf Bolus (sulfamethazine), NADA 120-615, 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 (sulfamethazine), NADA 120-615, resulted in an illegal 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. 530, you cause 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 Yvette I. Johnson, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Johnson at (215) 717-3077 or e-mail at Yvette.Johnson@fda.hhs.gov.
 
                                                                                               
Sincerely,
/S/ 
Kirk D. Sooter
District Director
Philadelphia District
 
 
Cc:       Dr. David R. Griswold, Acting Director
            Pennsylvania Department of Agriculture
            Bureau of Animal Health and Diagnostic Services (BAHDS)
            2301 Cameron Street
            Harrisburg, Pennsylvania 17120
 
            Dr. Isabel Arrington, Director TA/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, Nebraska 68102
 
            Dr. Thomas Alexander
            Chief of Regulation and Compliance
            Pennsylvania Department of Agriculture
            Bureau of Animal Health
            Room 408
            2301 North Cameron Street
            Harrisburg, Pennsylvania 17120