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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Johann Dairy 3/6/13

  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
Pacific Region
1431 Harbor Bay Parkway
Alameda, CA 94502-7070 
Telephone:    510-337-6700
FAX:    510-337-6701 

 

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Our Reference: 3006258214
 
WARNING LETTER
 
March 6, 2013
 
Mr. John B. Verwey (Father), Co-Owner
Mrs. Ann M. Verwey, Co-Owner
Mr. John B. Verwey (Son), Co-Owner
Johann Dairy
11511 West Floral Avenue
Fresno, California 93706-8935
 
Dear Messrs Verway and Mrs. Verway:
 
On October 9, 11, and 18, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 11511 West Floral Avenue, Fresno, California. 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, our investigation revealed that on or about March 30, 2012, you sold a lactating dairy cow identified with ear tag (b)(4) (subsequently back tagged (b)(4), for slaughter as food.  On or about March 30, 2012, (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 penicillin at 0.08 parts per million (ppm) in the kidney and sulfamethazine at 0.122 ppm in the liver and 0.109 ppm in the muscle tissue. The FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, 556.510 (21 C.F.R. 556.510). The FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked tissues of cattle as codified in 21 C.F.R. 556.670. However, this tolerance does not apply to the use of (b)(4) (sulfamethazine sustained release bolus), in female dairy cattle over 20 months of age (lactating dairy cows). FDA has not established a tolerance for residues of sulfamethazine in the edible tissues of lactating dairy cows.  As such, there is no acceptable level of residue associated with the use of this drug in lactating cows.  The presence of these drugs in edible tissues from this animal in the amounts noted above 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 revealed that on or about May 29 and June 29, 2012, you sold two lactating dairy cows, identified with ear tags (b)(4) (subsequently back tagged (b)(4), for slaughter as food.  On or about May 29 and June 30, 2012, (b)(4), slaughtered these animals.  USDA/FSIS analysis of tissue samples collected from these two animals identified the presence of gentamicin in the kidney tissue. FDA has not established a tolerance for residues of gentamicin in the edible tissues of dairy cows.  As such, there is no acceptable level of residue associated with the use of this drug in dairy cows.  The presence of this drug in edible tissues from these animals 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 revealed that on or about May 2 and June 4, 2012, you sold two bob veal calves, identified with back tags (b)(4), for slaughter as food. On or about May 2 and June 4, 2012, (b)(4), slaughtered these animals. USDA/FSIS analysis of tissue samples collected from these two animals identified the presence of neomycin at 30.83 ppm and 56.14 ppm in the respective kidney tissues of each animal.  The FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in 21 C.F.R. 556.430. However, this tolerance does not apply to use of (b)(4) (Neomycin Sulfate) Soluble Powder, (b)(4), in calves to be processed for veal. As such, there is no acceptable level of residue associated with the use of this drug in veal calves. The presence of this drug in edible tissues from these animals in the amounts noted above 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 complete 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 (b)(4) (Sterile Penicillin G Procaine Injectable Suspension), (b)(4) (Sulfamethazine Sustained Release Bolus), (b)(4) Gentamicin Sulfate Solution (Gentamicin Sulfate), (b)(4) (Neomycin Sulfate) Soluble Powder, (b)(4). Specifically, our investigation revealed that you did not use penicillin G procaine, sulfamethazine bolus, gentamicin sulfate, and neomycin sulfate as directed by their approved labeling or your servicing veterinarian’s prescription. Use of these drugs in this manner is an extralabel use, as defined under 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 (b)(4) (Sterile Penicillin G Procaine Injectable Suspension), (b)(4), to one of your lactating dairy cows, identified with ear tag (b)(4), without following the dosage amount per injection site as stated by its approved labeling and your servicing veterinarian’s prescription. Your extralabel use (b)(4) (Sterile Penicillin G Procaine Injectable Suspension), (b)(4), 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) (Sterile Penicillin G Procaine Injectable Suspension), (b)(4), resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). You also administered (b)(4) (Sulfamethazine Sustained Release Bolus), (b)(4), to your lactating dairy cow, identified with ear tag (b)(4), without following the approved label directions.  The approved labeling for (b)(4) (Sulfamethazine Sustained Release Bolus), (b)(4), states that this product is not to be used in dairy cattle 20 months of age or older. Sulfamethazine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9), and your use of (b)(4) (Sulfamethazine Sustained Release Bolus), (b)(4), in a lactating dairy cow resulted in an illegal residue in violation of 21 C.F.R. 530.11(c).  Because your use of these drugs was not in conformance with their approved labeling or your servicing veterinarian’s prescription 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).
 
Our investigation also found that you administered (b)(4) Gentamicin Sulfate Solution (Gentamicin Sulfate), (b)(4), to two of your dairy cows, identified with ear tags (b)(4), without following the slaughter withdrawal time and record keeping requirement as stated by your servicing veterinarian’s prescription. Your extralabel use of (b)(4) Gentamicin Sulfate Solution (Gentamicin Sulfate), (b)(4), was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a), and your extralabel use of gentamicin sulfate resulted in two illegal drug residues, in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with your servicing veterinarian’s prescription 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).
 
Our investigation also found that you administered (b)(4) (Neomycin Sulfate) Soluble Powder, (b)(4), to two of your bob veal calves, identified with back tags (b)(4), without following the animal class as stated in the approved labeling.  Your extralabel use of (b)(4) (Neomycin Sulfate) Soluble Powder, (b)(4), 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) (Neomycin Sulfate) Soluble Powder, (b)(4), resulted in illegal residues, 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).
 
In addition, you adulterated (b)(4) (Neomycin Sulfate) Soluble Powder, (b)(4), 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 within the meaning of 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 Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov
 
Sincerely, 
/S/
Judy Strojny
Acting District Director
San Francisco District
U. S. Food and Drug Administration