FDA WARNING_LETTER - Rocky Ford Pet Foods - February 27, 2013

The FDA conducted an inspection of Rocky Ford Pet Foods' rendering facility from February 25-27, 2013, revealing significant deviations from regulations 21 CFR 589.2000 and 21 CFR 589.2001, aimed at reducing Bovine Spongiform Encephalopathy (BSE) risk. The facility processes "cattle materials prohibited in animal food or feed" (CMPAF), and its non-compliance resulted in adulterated and misbranded products under the Federal Food, Drug, and Cosmetic Act. Violations included failure to prevent CMPAF inclusion in animal feed, inadequate written procedures for removing brain and spinal cord from older cattle, failure to mark CMPAF with a detectable agent, failure to label CMPAF containers with "Do not feed to animals," and failure to avoid cross-contamination of CMPAF. For example, unmarked CMPAF vertebral columns were commingled, and written procedures were inconsistent with actual operations. The FDA requires prompt corrective action and a system to prevent recurrence. Rocky Ford Pet Foods must respond in writing within fifteen working days, detailing corrective steps and providing supporting documentation. Failure to comply may lead to regulatory actions like seizure or injunction, underscoring the firm's responsibility for overall compliance.