# FDA WARNING_LETTER - South Pork Ranch Equipment LLC - September 20, 2022

Source: https://www.keypedia.com/records/warning_letter/south-pork-ranch-equipment-llc/d72f021e-511b-4bfd-8d11-2b7a6eec2061

> FDA WARNING_LETTER for South Pork Ranch Equipment LLC on September 20, 2022. Product: Veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: South Pork Ranch Equipment LLC
- Inspection Date: 2022-09-20
- Product Type: Veterinary
- Office Name: Center for Veterinary Medicine
- Summary: The FDA issued a Warning Letter to James Fuller regarding the marketing of unapproved animal drug products, including Cydectin (moxidectin), Cydectin with Blackstrap Iron Supplement, and Blackstrap, through eBay and Craigslist accounts under "goatandchickenman" and "South Pork Ranch Equipment."

The FDA determined these products are unapproved new animal drugs under section 201(g)(1)(B) of the FD&C Act, as they are intended for disease treatment in animals. Claims observed on the websites indicate uses for deworming cattle, sheep, and goats, and treating anemia due to worm infestation. Specifically, Cydectin was marketed for oral administration in sheep and goats, and Blackstrap as an iron supplement for anemia caused by worms.

While an approved Cydectin (moxidectin) pour-on product exists for cattle, the products sold by Fuller are not approved or labeled for use in sheep or goats, or for oral administration. The letter notes misleading implications that the sold products are the FDA-approved Cydectin.

These products are considered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act, making their introduction into interstate commerce prohibited under section 301(a). Fuller is required to respond within fifteen working days, detailing corrective actions, preventing recurrence, and providing supporting documentation. Failure to comply may result in legal action, including

## Related Officers

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Company: https://www.keypedia.com/companies/south-pork-ranch-equipment-llc/309d26b9-2e17-4796-a3de-b0a80f17951b

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4