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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

White Egret Farm 15-Dec-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




December 15, 2004

2005-DAL-WL-08

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms . Lee B. Dexter, Owner
White Egret Farm
15704 Webberville Road
Austin, Texas 78724

Dear Ms. Dexter:

We inspected your firm located at 15704 Webberville Road, Austin, Texas 78724, from July 28 through August 6, 2004. During this inspection, our investigators documented violations of the Public Health Service Act (PHS Act) and a Federal regulation promulgated under the PHS Act.

Our inspection determined that your firm distributes unpasteurized goat milk in interstate commerce, in finished form for human consumption. Such distribution is a violation of the PHS Act, 42 U.S.C. §§ 264(a) and 271(a), and the implementing regulation codified in Title 21, Code of Federal Regulations (CFR), section 1240.61(a) . The regulation bans the delivery, sale, or distribution in interstate commerce of milk and milk products in final package form for human consumption unless they have been pasteurized. Your goat milk is a "milk product" as that term is defined by 21 C.F.R. § 1240.3{j). Further, your goat milk, shipped directly to customers for consumption without subsequent processing and pasteurization, is in final package form for human consumption. For your information, we have enclosed a copy of the regulation as it was published in the Federal Register, 52 FR 29,509 (Aug 10, 1987).

The above observation is not intended to be an all-inclusive list of violations. It is your responsibility to ensure adherence with all requirements of the PHS Act and implementing regulations. You should take prompt action to correct this deviation and prevent any future recurrence . Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure, injunction and/or prosecution.

Please notify this office in writing, within 15 working days of receipt of 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 actions can not be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.

Your response should be sent to Sherrie L. Krolczyk, Recall and Emergency Coordinator at the above letterhead address. If you have questions regarding any issue in this letter, please contact Ms. Krolczyk, at 214-253-5222.

Sincerely,

/s/
Michael Chappell
Dallas District Director