# FDA 483 - Rough Diamond Dairy - June 17, 2024

Source: https://www.keypedia.com/records/483/rough-diamond-dairy/35ffdec4-c6a9-46be-8aca-d5b4b7a84838

> FDA 483 for Rough Diamond Dairy on June 17, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rough Diamond Dairy
- Inspection Date: 2024-06-17
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: Rough Diamond Dairy underwent an FDA inspection from May 9 to June 17, 2024, which identified significant compliance issues documented in a Form FDA 483. The primary concern was the extralabel use of approved human or animal drugs, leading to residues exceeding established safe levels in a dairy cow sold for human consumption. Specifically, Florfenicol and Sulfadimethoxine were found in the animal's liver above their respective tolerances. This violation stemmed from administering Florfenicol, intended for calves, to an adult cow, and failing to adhere to adequate withdrawal periods when using combined medications. The inspection also noted that the dairy did not follow prescribed drug directions, administering Ampicillin Trihydrate for durations longer than specified by manufacturer labels. Additionally, treatment records were incomplete, often missing vital details such as the condition treated, dosage, administration route, and the individual who administered the drug. These observations indicate a need for improved adherence to regulations concerning drug administration and documentation in food-producing animals to ensure consumer safety. The firm is expected to address these findings with appropriate corrective actions.

## Related Documents

- [483 - 2024-06-17](https://www.keypedia.com/records/483/rough-diamond-dairy/2ff56bf3-c4bc-4dcf-bde6-c7c1a24a3340)

## Related Officers

- [Supervisory Wildlife Inspector, Agriculture Specialist,  Animal Health Technician](https://www.keypedia.com/people/christi-l-bellmore/7a8bd842-109c-4efb-ac84-e171806bbfbb)

Company: https://www.keypedia.com/companies/rough-diamond-dairy/33ed92bf-f290-4040-9b0d-bc14f9c7a0d4

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03