# FDA 483 - Raw Farm LLC - October 09, 2019

Source: https://www.keypedia.com/records/483/raw-farm-llc/2a59c918-d68b-4e56-93e1-4bb77b2c609b

> FDA 483 for Raw Farm LLC on October 09, 2019. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Raw Farm LLC
- Inspection Date: 2019-10-09
- Product Type: veterinary
- Office Name: Office of Compliance Intervention and Consultation
- Summary: During an inspection conducted from September 23 to October 9, 2019, the FDA observed significant deviations at Organic Pastures Dairy Company LLC, a manufacturer of raw milk and raw milk products. The inspection revealed that the company was not adhering to the requirements of a permanent injunction (Case1:08-CV-01786-OWW-GSA) issued in April 2010. Key violations included the continued introduction of raw milk products, specifically Raw Organic Grass-Fed Kefir pet food, into interstate commerce without prior written authorization from the FDA, a repeat observation from a previous inspection. Furthermore, the company failed to include the mandatory statement regarding the cessation of interstate commerce for unpasteurized raw milk products on retail invoices and packaging slips, also a repeat issue. The inspection also found that Organic Pastures Dairy Company LLC displayed prohibited health benefit claims for raw milk, such as its supposed ability to reduce asthma, on its Facebook page. Lastly, the firm failed to provide proper notice to its commercial buyers that raw milk and raw milk products are restricted to intrastate distribution within California, another repeat observation. To achieve compliance, the company is required to promptly cease all unauthorized interstate distribution of raw milk products, ensure all retail documentation carries the specified disclaimer, remove all promotional materials with unauthorized health claims, and properly notify commercial buyers about the intrastate sales limitation, thereby adhering to the terms of the existing injunction and the Federal Food, Drug, and Cosmetic Act.

## Related Documents

- [483 - 2016-09-29](https://www.keypedia.com/records/483/raw-farm-llc/c94e8d67-b42c-4e9f-8b8f-79029c54489c)
- [483 - 2016-09-29](https://www.keypedia.com/records/483/raw-farm-llc/8fb15c96-dd2b-4d64-bbc1-5709b41d38c0)
- [483 - 2019-10-09](https://www.keypedia.com/records/483/raw-farm-llc/c34e3c62-744b-458c-8b56-a77f0c258caf)
- [EIR - 2021-02-12](https://www.keypedia.com/records/eir/raw-farm-llc/7e86c51e-75ed-4aa7-9806-3c7e7cc07115)
- [483 - 2021-02-12](https://www.keypedia.com/records/483/raw-farm-llc/926bff0a-0f4f-464b-92e4-20561ac4ad9b)

## Related Officers

- [Director](https://www.keypedia.com/people/joann-m/0a459cd4-7849-4687-8811-4868144e3be3)
- [Ismael Garibay](https://www.keypedia.com/people/ismael-garibay/bfdbc1b6-8822-4cc6-9cef-7f8ae0c1c04e)

Company: https://www.keypedia.com/companies/raw-farm-llc/126029a1-a19e-4717-bb23-5408e615f343

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54