# FDA WARNING_LETTER - Rancho Cantera - November 26, 2012

Source: https://www.keypedia.com/records/warning_letter/rancho-cantera/75ba5181-1ebd-4ccb-bbf5-a42608a4d935

> FDA WARNING_LETTER for Rancho Cantera on November 26, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rancho Cantera
- Inspection Date: 2012-11-26
- Product Type: Drugs
- Office Name: Chicago District Office
- Summary: On November 19 and 26, 2012, the FDA investigated Rancho Cantera, LLC, a dairy farm in Kent, Illinois, and found violations of the Federal Food, Drug, and Cosmetic Act. A Holstein dairy cow sold for slaughter on June 18, 2012, was found to have a violative residue of 0.11 ppm of ampicillin in its kidney, exceeding the 0.05 ppm tolerance level for penicillin in cattle, rendering the food adulterated under Section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions where medicated animals with harmful drug residues could enter the food supply, specifically due to the failure to maintain complete treatment records and a drug inventory system. Furthermore, the new animal drug Polyflex Ampicillin for injectable Suspension, NADA 55-030, was adulterated because it was used extralabelly without the supervision of a licensed veterinarian, violating 21 C.F.R. Part 530.11(a) and causing the drug to be unsafe and adulterated under Sections 512(a) and 501(a)(5) of the FD&C Act, respectively.

Rancho Cantera's December 5, 2012, response, which described steps to revise treatment protocols, was acknowledged.

## Related Officers

- [William J. Croatt](https://www.keypedia.com/people/william-j-croatt/470d7bde-400e-4eea-b15b-d3caac0fcd7a)
- [Scott J. Macintire](https://www.keypedia.com/people/scott-j-macintire/ca3dc0d0-ffd3-4d61-bd98-56aa7d8b15af)

Company: https://www.keypedia.com/companies/rancho-cantera/c8cd82b6-431e-4bba-be2a-885603f49b43

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669