Inspections, Compliance, Enforcement, and Criminal Investigations
Bowerman, Freddie J. & Letitia 25-Aug-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
| Minneapolis District Office |
4040 North Central Expresauray
Dallas, Texas 75204-3145
August 25, 2005
RETURN RECEIPT REQUESTED
Mr. & Mrs. Freddie J. and Letitia Bowerman, Owners
3445 CR 1580
Ada, Oklahoma 74820
Dear Mr. and Mrs. Bowerman:
An investigation of your cow/calf operation at the above location conducted by a representative of the U.S. Food and Drug Administration (FDA) on May 5 and 10, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) (21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) (21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about February 25, 2005, you sold a cow identified with ear tag #73CME5095 that was subsequently slaughtered as food at [redacted]. On or about February 24, 2005, animal was slaughtered at [redacted]. United States Department of Agriculture, Food Safety an inspection Service (USDA/FSIS) analysis of tissue samples collected from that
animal identified the presence of residues of 1.25 parts per million (ppm) and 1.13 ppm Sulfadimethoxine in the fiver and muscle tissues, respectively. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations(C.F.R, Section 556.640 (21 C.F.R. 556.640). The presence of this drug at levels above the established tolerance in the edible tissues of this animal 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. You lack an adequate system to ensure that those animals medicated by you have been Withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain written treatment records documenting the date, the drug administered, the dosage, the route of administration, and the drug withdrawal time. This information would help you determine if animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potently hazardous residues of drugs from edible tissues. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C . § 342(a)(4)).
For your information, our investigators also observed a number of expired new animal drugs in refrigerated storage. Using an expired new animal drug to treat your animals would result in the drug being unsafe within the meaning of section 512(a) of the 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 new animal drug is adulterated within the meaning of section 501(a)(5) t21 U.S.C. § 351(a)(5)). You should- be aware that extralabel use of approved animal and human drugs is only permitted if the use is on or by the lawful order of a licensed veterinarian within the -context' of a valid veterinarian-client-patient relationship and such use complies with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. §§ 360b(a)(4) and (a)(5)] and the extralabel use regulations set forth in 21 C.F.R. Part 530.
You also signed a Bill-In Ticket to [redacted] on February. 24, 2005, providing assurance to [redacted] and to prospective livestock buyers, that the animal contained no illegal drug residues. If you continue to medicate animals without maintaining the treatment records described above, you may be giving a false guaranty. Giving a false guaranty is prohibited by section 301(h) of the Act.
The above is not intended to be an all-inclusive list of violations. We are in receipt of your May 11, 2005, written response to the inspection and Form FDA-483. You state that you will 'keep better records and have contacted your veterinarian regarding the destruction of expired drugs. Your response is not satisfactory; you have not provided information about the controls you plan to administer, or the type(s) of records to be maintained to ensure that drug residues do not occur in animals offered for slaughter for food. 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 above violations and to establish procedures whereby such 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, 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 James R. Lahar, Compliance Officer, U .S. Food and Drug Administration, at the above letterhead address.
Michael A. Chappell
Dallas District Director