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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Bear Creek Veterinary Services 08-May-07

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

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


 

VIA FEDERAL EXPRESS

Our Reference: 3005985934

May 8, 2007

James R. Correa, D.V.M., Owner
Bear Creek Veterinary Services
6550 East South Bear Creek Drive
Merced, California 95340

WARNING LETTER

Dear Dr. Correa,

On November 7 and December 14, 2006, an investigator from the U.S. Food & Drug Administration (FDA) conducted an inspection involving the use of drugs in your veterinary practice. That inspection revealed that you caused animal drugs to be unsafe under section 512(a) [21 U.S.C. § 360b] of the Federal Food, Drug, and Cosmetic Act (the Act) and therefore adulterated within the meaning of section 50l(a)(5) [21 U.S.C. § 351(a)(5)] of the Act because the drugs were used in a manner that did not conform with their approved uses or with sections 512{a)(4) [21 U.S.C.§ 360(b)(a)(4)] and 512(a)(5)[21 U.S.C.§ 360(b)(a)(5)] of the Act and the codified regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (21 C.F.R.); Part 530. 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 January 24, 2006, the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) detected the presence of [redacted] in the kidney of a dairy cow identified as originating from [redacted]. This cow was slaughtered at [redacted] (USDA sample 463497). There is no allowable tolerance for [redacted] in the edible tissues of cattle.

The Food and Drug Administration (FDA) performed an investigation at [redacted] and determined the cow did originate from the farm but was not treated with [redacted] at this farm. The animal was raised as a calf from January 10, 2004, through May 19, 2004, at [redacted] under contract with [redacted]. An FDA inspection of [redacted] determined this was where the animal had been medicated and the ranch uses the veterinary services of Bear Creek Veterinary Service.

You prescribed drugs to be used in an extralabel manner by [redacted]. For example, you prescribed [redacted] for treatment of bacterial scours and septicemia in cattle. [redacted] is not approved for use in cattle. You prescribed penicillin G procaine for use at a dose of [redacted] cc whereas the approved dose is 1 cc per 100 pounds. The extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with sections 512(a)(4)[21 U.S.C.§ 360(b)(a)(4)) and 512(a)(5)[21 U.S.C.§ 360(b)(a)(5)] of the Act and 21 C.F.R Part 530. Our inspection found that you failed to comply with these requirements in that, for example, you did not:

• Make a careful diagnosis and evaluation of the conditions for which the drug is to be used.

• Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information.

• Institute procedures to assure the identity of the treated animal(s) was carefully maintained.

• Take appropriate measures to assure that no illegal drug residues occurred in any
food producing animals subjected to the extralable treatment.

• Comply with the labeling requirements in 21 C.F.R. 530.12(c) in that you failed to provide the route of administration for the drug [redacted] and you failed to correctly identify the animals to be treated with [redacted] and [redacted] since you prescribed these drugs for use in cows at a calf ranch.

• Establish a valid veterinarian-client-patient relationship, as set out in 21 C.F.R.530.3(i). You stated during our inspection that you do not examine sick animals at your client's firms since the herdsmen were seeing the animals on a daily basis and they are more familiar with the animals' health conditions.

You caused the aforementioned animal drugs to be unsafe under § 512(a) of the Act [21 U.S.C. § 360b(a)] and adulterated within the meaning of § 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] because you caused the drugs to be used in a manner that did not conform with their approved uses or the regulations for extralabel drug use in animals, 21 CFR Part 530.

We also note that you prescribed the [redacted] and [redacted] which are intended for use in dairy cows, for use at [redacted] when there are no cows at this ranch.

Although you responded to our inspection in writing in a letter to our San Francisco District Office dated December 27, 2006, we find the steps and procedures in this letter to be inadequate as they do not address procedures to as sure the identity of treated animals is maintained or establish methods for you to examine animals or evaluate medical conditions before prescribing drugs in an extralabel manner. In addition, an FDA investigator visited two pharmacies dispensing drugs to one of your clients, and obtained copies of prescriptions you authorized after the date of the December 27, 2006, letter. These prescriptions failed to provide adequate directions for use.

The above is not intended to be an all-inclusive list of violations. As a licensed veterinarian, you are responsible for complying with the requirements of the Act, including the extralabel use regulations promulgated under the Act. 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 injunction.

We have enclosed a copy of 21 C.F.R. Part 530 for your reference. We strongly suggest that you review 21 C.F.R. Part 530 and become familiar with all of its requirements so that you can prevent future violations of the Act.

You should notify this office in writing within fifteen (15) working days of receiving this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. 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 response should be directed to Karen L. Robles, Consumer Safety Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, please contact Karen Robles at (916) 930-3674, ext. 114.

Sincerely,

/S/

Barbara J. Cassens
District Director
San Francisco District