WARNING LETTER
Douglas Chambers Dairy Inc. MARCS-CMS 526859 —
- Delivery Method:
- UPS
- Product:
- Animal & Veterinary
- Recipient:
-
Recipient NameMs. Mary Watts
- Douglas Chambers Dairy Inc.
300 Mayzine Dairy Road
Macon, GA 31217
United States
- Issuing Office:
- Atlanta District Office
United States
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Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
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September 26, 2017
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
Ms. Mary Watts, Owner
Douglas Chambers Dairies, Inc.
300 Mayzine Dairy Road
Macon, Georgia 31217
WARNING LETTER
(17-ATL-11)
On April 24, 26, and 28, 2017 the U.S. Food & Drug Administration (FDA) conducted an investigation of your dairy operation located at 300 Mayzine Dairy Road, Macon, Georgia. 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.
Our investigation 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 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 adequate treatment records. Specifically, your records did not include the drug administered, dosage given, route of administration, and the withdrawal time required for meat and milk. Further, you did not have a system in place to review treatment records prior to offering an animal for slaughter for human food, to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed. You also failed to maintain an adequate inventory system for determining the quantities of drugs used to medicate your animals which include the list of drugs, quantities, lot numbers, date used or expiration dates. You also fail to segregate treated animals. Both hospital pens at your farm are used to store both medicated and non-medicated cows in an intermingled manner. Treated cows are not quarantined, segregated or identified as medicated at any time, including storage in hospital pens.
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)).
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.
Since the close of the inspection, we have not received a written response from you that addresses the steps you will be taking to correct the deficiencies we identified during our inspection.
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 written response should be sent to Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, NE, Atlanta, GA 30309. If you have any questions about this letter please contact Compliance Officer King at (843) 746-2990 x16 or via email at janice.king@fda.hhs.gov.
Sincerely,
/S/
Ingrid A. Zambrana
District Director
U.S. Food & Drug Adminisration
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
Office of Regulatory Affairs
cc:
Mr. James D. Chambers, Manager
Douglas Chambers Dairy, LLC
300 Mayzine Dairy Road
Macon, GA 31217
Dr. Paul E. Johnson
195 Cedar Grove Road
Climax, Georgia 39834