FDA WARNING_LETTER - Tom Schantz Farm (d/b/a Riverview Dale Farm) - February 12, 2010

On February 10-12, 2010, the FDA inspected Thomas Schantz Farm d/b/a Riverview Dale Farm. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow shipped on August 6, 2009, and slaughtered on August 7, 2009, contained 8888.0 ppm of phenylbutazone in kidney tissue, for which FDA has no established tolerance. This constitutes adulteration under 21 U.S.C. § 342(a)(2)(C)(ii) because phenylbutazone is prohibited for extralabel use in female dairy cattle 20 months or older (21 CFR 530.41(a)(12)).

The farm also failed to maintain treatment records, leading to adulteration under 21 U.S.C. § 342(a)(4) due to insanitary conditions where medicated animals with harmful residues could enter the food supply.

Furthermore, the farm illegally used Phenylbute Injection 20% (Phenylbutazone) and Penicillin G Procaine Injectable Suspension USP. Phenylbutazone was administered extralabel to a 58-month-old female dairy cow, violating 21 CFR 530.41(a)(12) and 21 CFR 53