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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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John Bootsma Dairy 11/28/11

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax          (949) 608-4415

 

 
WARNING LETTER
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                                                                    
 
 
November 28, 2011
                                                                                                                                                W/L 12-12
John Bootsma, Co-Owner
Essie L. Bootsma, Co-Owner
John Bootsma Dairy
32190 Ramona Expressway
Lakeview, CA 92567-9107
 
Dear Mr. and Mrs. Bootsma:
 
On August 1, 8 and 30, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 32300 Ramona Expressway, Lakeview, California 92567-9118. 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 May 4, 2011, you sold a dairy cow, identified with ear tag (b4), for slaughter as food. On or about May 4, 2011, (b4), 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 flunixin at 0.174 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.286 (21 C.F.R. 556.286). 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 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).
 
Our investigation found that you administered (b4) (Flunixin Meglumine Injectable Sterile Solution, 50 mg/ml, ANDA (b4), to a dairy cow without following the withdrawal period. Your extralabel use of (b4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 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).
 
We also found that you adulterated the new animal drugs (b4) (Penicillin G Procaine Injectable Suspension, NADA (b4), (b4) (Pirlimycin Hydrochloride Sterile Solution, NADA (b4), (b4) Sterile Powder(Ceftiofur Sodium Sterile Powder, NADA (b4), (b4) (Ceftiofur Hydrochloride Injectable Sterile Suspension, NADA (b4), (b4) (Ceftiofur Hydrochloride Sterile Suspension, NADA (b4), and (b4) (Dexamethasone 2 mg/ml Sterile Suspension, ANADA (b4). 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. See 21 C.F.R. 530.3(a). 
 
The extralabel use of approved animal or human drugs in animals is allowed under the 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 also found that you administered (b4) (Penicillin G Procaine Injectable Suspension, NADA (b4) to your dairy cows without following the dose, route of administration, and specified condition to be treated as stated in the approved labeling.  Your extralabel use of (b4) was not under the supervision of a licensed veterinarian which is in violation of 21 C.F.R. 530.11(a). 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).
 
Our investigation also found that you administered (b4) (Ceftiofur Hydrochloride Sterile Suspension, NADA (b4) and (b4) (Pirlimycin Hydrochloride Sterile Solution, NADA (b4), to your dairy cows without following the duration and frequency of treatment and pre-slaughter withdrawal time as stated in the approved labeling. Your extralabel use of (b4) and (b4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with their 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).
 
Our investigation also found that you administered (b4) (Ceftiofur Sodium Sterile Powder, NADA (b4), (b4) (Ceftiofur Hydrochloride Injectable Sterile Suspension, NADA (b4), (b4) (Ceftiofur Hydrochloride Sterile Suspension, NADA (b4), and (b4) (Dexamethasone 2 mg/ml Sterile Suspension, ANADA (b4) to your dairy cows without following the meat withdrawal period as stated in the approved labeling. Your extralabel use of these drugs was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with their 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 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. 
 
Our investigators also observed a number of expired animal drugs in refrigerated storage. Using an expired animal drug to treat your animals would result in the drug being unsafe within the meaning of section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), because such use would be in a manner other than in accordance with the drug's approved application. An unsafe animal drug is adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). 
 
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 response should be sent to:
 
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
 
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
 
 
Cc:     
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA   95899-7413