# FDA WARNING_LETTER - Cross Country Dairy - October 26, 2012

Source: https://www.keypedia.com/records/warning_letter/cross-country-dairy/a318409f-6f69-4a84-a44a-9c8e7426c91d

> FDA WARNING_LETTER for Cross Country Dairy on October 26, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cross Country Dairy
- Inspection Date: 2012-10-26
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: On December 13, 2012, the FDA issued a Warning Letter to Cross Country Dairy following an investigation from October 23-26, 2012. The letter states that the dairy offered adulterated animals for slaughter as food, violating sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specifically, on May 1, 2012, a dairy cow sold by Cross Country Dairy for slaughter contained 1.54 ppm Penicillin in kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 CFR 556.510). A second cow sold on May 21, 2012, also showed 1.54 ppm Penicillin in kidney tissue.

The investigation also found that Cross Country Dairy held animals under insanitary conditions, failing to maintain an adequate system to ensure medicated animals were withheld from slaughter for appropriate withdrawal periods. The dairy also failed to maintain and review complete treatment records for medicated animals sold for food, despite admitting to treating the subject cows with penicillin.

The FDA acknowledged the dairy's November 6, 2012, response to the FDA 483 but deemed it inadequate due to a lack of documentation for corrective actions. Cross Country Dairy was required to respond within fifteen working days, detailing

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