FDA WARNING_LETTER - Daniel W. Siegert DBA Siegert Swiss - November 16, 2012

On November 14-16, 2012, the FDA investigated Siegert Swiss's dairy operation in Peosta, Iowa, finding violations of the Federal Food, Drug, and Cosmetic Act. The primary issue was the sale of adulterated animals for slaughter.

Specifically, on August 28, 2012, a dairy cow sold for slaughter contained 5.5 ppm of Desfuroylceftiofur (a Ceftiofur marker) in its kidney, exceeding the 0.4 ppm tolerance (21 C.F.R. § 556.113). Similarly, on September 6, 2012, another dairy cow sold for slaughter had 2.42 ppm of Desfuroylceftiofur in its kidney, also above the tolerance. These levels caused the food to be adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the investigation revealed insanitary conditions, including a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the Act.

Siegert Swiss must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective actions and timelines is