Inspections, Compliance, Enforcement, and Criminal Investigations

Balmer Brothers 1/14/15

  

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
15-PHI-08
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
January 14, 2015
 
 
Mr. Dale L. Balmer, Partner
Mr. Cletus Balmer, Partner
Balmer Brothers
1102 Breneman Road
Manheim, Pennsylvania 17545
 
Dear Messrs. Balmer:
 
On September 23, and 25, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 1102 Breneman Road, Manheim, 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 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 revealed that on or about January 30, 2014, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about January 31, 2014, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the bob veal calf with back tag (b)(4) identified  the presence of neomycin at 12.68 parts per million (ppm) in the kidney tissue. Our investigation also revealed that, on or about February 27, 2014, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about February 28, 2014, (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 neomycin at 10.27 ppm in the kidney tissue. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 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 Dairy Herd & Beef Calf Milk Replacer (Neomycin Sulfate/Oxytetracycline, (b)(4)) in calves to be processed for veal (pre-rumination calves), and there is no acceptable level of residue associated with the use of this drug in veal calves. 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 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 Dairy Herd & Beef Calf Milk Replacer ((b)(4)) - (containing neomycin sulfate and oxytetracycline).  Specifically, our investigation revealed that you did not use (b)(4) Medicated Dairy Herd & Beef Calf Milk Replacer ((b)(4)) - (containing neomycin sulfate and oxytetracycline) as directed by its approved labeling. Use of these drugs in this manner is an extra-label use, as defined under (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 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 (b)(4) Medicated Dairy Herd & Beef Calf Milk Replacer to a bob veal calf with back tag (b)(4) and to a bob veal calf with back tag (b)(4), a class of animal not set forth in the approved labeling. Your extralabel use of (b)(4) Medicated Dairy Herd & Beef Calf Milk Replacer was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R.530.11(a) and your extralabel use of (b)(4) Medicated Dairy Herd & Beef Calf Milk Replacer 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 Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).
 
In addition, you adulterated (b)(4) Medicated Dairy Herd & Beef Calf Milk Replacer ((b)(4)) - (containing neomycin sulfate and oxytetracycline) 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 the 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.
 
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 Ms. Yvette 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/ 
Anne E. Johnson
Acting District Director
Philadelphia District Office
 

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