James D. Hudson Livestock – FDA Warning Letter, Feb 14, 2019

On April 11, 2019, the FDA issued a Warning Letter to James D. Hudson Livestock following an investigation conducted on February 5, 13-14, 2019, at their beef cattle grower operation in Caneyville, Kentucky. This investigation was prompted by a ciprofloxacin residue found in a slaughtered cow.

The FDA found that the operation holds animals under conditions likely to result in medicated animals with harmful drug residues entering the food supply. Key violations include: * Lack of a system to ensure appropriate drug withdrawal periods for medicated animals. * Failure to maintain treatment records. * Lack of an adequate system to identify medicated animals. * Reuse of contaminated syringes, leading to drug contamination (e.g., a discolored injectable solution due to syringe reuse). * Failure to maintain syringes in a well-cleaned state. * Storage of expired drugs, including products expired in January 2015, September 2018, August 2017, and March 2016.

These conditions render food from such animals adulterated under Section 402(a)(4) of the FD&C Act. The letter requires prompt corrective actions and procedures to prevent recurrence. A written response detailing steps taken or planned must be submitted within fifteen working days of receipt, with explanations for any delays. Failure to comply may result in regulatory actions