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WARNING LETTER
•Douglas Chambers Dairy Inc.•April 28, 2017

FDA WARNING_LETTER - Douglas Chambers Dairy Inc. - April 28, 2017

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Record Details

On April 24, 26, and 28, 2017, the FDA inspected a dairy operation at 300 Mayzine Dairy Road, Macon, Georgia, and issued Warning Letter 17-ATL-11 for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The investigation found inadequate conditions likely to result in medicated animals with harmful drug residues entering the food supply, rendering the food adulterated under section 402(a)(4) of the FD&C Act.

Specific violations include: * Lack of an adequate system to ensure appropriate drug withdrawal times for medicated animals. * Failure to maintain adequate treatment records, specifically missing drug administered, dosage, route of administration, and withdrawal times for meat and milk. * Absence of a system to review treatment records before slaughter to ensure proper drug use and withdrawal times. * Failure to maintain an adequate drug inventory system, lacking details such as drug lists, quantities, lot numbers, and expiration dates. * Failure to segregate treated animals; both hospital pens intermingled medicated and non-medicated cows, with no quarantine, segregation, or identification of medicated animals.

The letter emphasizes the producer's responsibility for overall compliance and warns that failure to correct violations promptly may lead to regulatory actions like seizure or injunction. The FDA had not received a written response addressing the deficiencies since the

Company
Douglas Chambers Dairy Inc.
Inspection Date
April 28, 2017
Product Type
Drugs
Office
Atlanta District Office
People
  • Ingrid A. Zambrana
  • James D. Chambers
  • Paul E. Johnson
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ID · 208dbda2-c558-4ca9-9cd2-57d3f3f20c53

Violation Codes2
FD&C Act 402(a)(4)21 U.S.C. 342(a)(4)

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