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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Chapman Ranch 10-Jun-04

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

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


June 10, 2004

Ref: 2004-DAL-WL-17

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Jack Chapman, Owner
Chapman Ranch
11071 CR 1255
Lampasas, TX 76550

Dear Mr. Chapman:

An inspection of your ruminant feeding operation located at 11071 CR 1255, Lampasas, Texas, was conducted on February 26 and March 1, 2004 by Investigators from the Food and Drug Administration (FDA). The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Section 589.2000 - Animal Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).

Our inspection revealed that you feed prohibited material, as defined by 21 CFR 589.2000(a), to ruminants. This prohibited material consists of manufacturing process stream waste from [redacted] a manufacturer of products such as fully cooked tacos, burritos, and taquitos that contain beef. This manufacturing process stream waste contains meat products that have been cooked and offered for human food but that have not been further heat processed for feed. This failure to further heat process the material causes the feed to be adulterated under section 402(a)(2)(C)(i) because it contains an unapproved food additive (i.e., the meat products that have not been further heat processed for feed).

At the close of the inspection, copies of the BSE Guidance documents 69, 70 and 76 were provided to you and further discussed. Also, you previously received a copy of 21 CFR 589.2000, the BSE regulation, which was again explained in more specific detail. You should know that this serious violation of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or injunction.

It is necessary for you to take action on this matter now. Please send a written response to this office within fifteen (15) working days from the date you receive this letter. Your response should specifically identify the actions you are taking to correct the violations and provide specific timeframes for achieving compliance. Also, as part of your written response, you should provide information regarding the current feeding practices followed at your facility and information pertaining to the planned marketing of your animals. Your reply should be sent to Edwin Ramos, Compliance Officer, at the above stated address. If you have any questions concerning this letter, you may contact Mr. Ramos at 214-253-5218.

Sincerely,

/s/

Michael A. Chappell
Dallas District Director