FDA WARNING_LETTER - Shur-Green Farms - November 19, 2014

The FDA conducted an inspection of Shur-Green Farms from October to November 2014, revealing significant violations of the Federal Food, Drug, and Cosmetic Act, resulting in the distribution of adulterated and misbranded animal food. The firm's response to the FDA Form 483 was inadequate, failing to outline remedies or preventive measures. Shur-Green Farms distributed "lascadoil," a waste byproduct for fuel containing lasalocid sodium (an active pharmaceutical ingredient), misrepresenting it as "soy oil" or "used cooking oil" suitable for animal feed. This product was found in customer animal feed samples. The lascadoil is adulterated under 402(a)(3) of the FD&C Act as it is unfit for animal food. It is further adulterated under 402(a)(2)(C)(i) as an unsafe food additive (sections 201(s) and 409), lacking a food additive regulation and not being GRAS for animal food. The firm's invoices and emails, constituting labeling under 201(m), were false or misleading, leading to misbranding under 403(a)(1). This is not the first instance, as a prior contamination event in July 2014 caused significant turkey losses and swine market holds. The firm must promptly correct these violations and implement recurrence prevention procedures. A written response detailing these actions, with documentation, is required within fifteen working days. Failure to comply may lead to enforcement actions like seizure or injunction.