FDA WARNING_LETTER - Cache Commodities Incorporated - December 14, 2017

The FDA issued a Warning Letter to Cache Commodities Incorporated following a December 14, 2017, inspection, a follow-up to a June 9, 2017, regulatory meeting, and an investigation into animal deaths. The inspection revealed numerous violations of Current Good Manufacturing Practice (CGMP) for animal food (21 CFR Part 507) and medicated feed (21 CFR Part 225), causing products to be adulterated and misbranded.

Specifically, Gamebird Starter Medicated was deficient in vitamin D, calcium, and phosphorus, linked to rickets in pheasant chicks. Previous issues included excessive vitamin D in rabbit feeds, causing toxicity. Laboratory analysis found Gamebird Starter Medicated and Halter Power Finisher Medicated to be subpotent in amprolium and monensin, respectively. Amino Pro Layer Crumble was misbranded due to inaccurate nutrient labeling (phosphorus, sodium, calcium).

CGMP violations included: 1. Failure to protect raw materials from contamination and deterioration (e.g., open, spilled, and dusty ingredients). 2. Failure to maintain clean and repaired facilities (e.g., deteriorating insulation, spilled ingredients, discarded snack items). 3. Failure to maintain grounds to prevent contamination (e.g., trash, old equipment, expired feed, overgrown vegetation). 4. Failure to exclude pests (e.g., dead raccoon, live cats, birds,