FDA WARNING_LETTER - International Specialty Supply Holding, Inc. - February 28, 2012

An FDA inspection of International Specialty Supply Holding, Inc.'s sprout growing facility in Cookeville, Tennessee, from February 8-28, 2012, revealed insanitary conditions causing fresh cut products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations included: 1. **Condensation and Water Issues:** Condensation dripped from walls/ceilings in multiple areas, including where sprouts were stored, with water pooling and mold accumulating in the Seed Receiving Room. 2. **Pest Control Deficiencies (21 CFR 110.35(c)):** An open culvert to the exterior, live and dead cockroaches, crickets, spiders, and termite trails were observed in various processing and storage areas. 3. **Inadequate Sanitary Facilities (21 CFR 110.37):** The men's restroom opened directly into the processing area, lacked a self-closing door, and was visually dirty. 4. **Insanitary Surfaces:** Product buildup on the de-hulling machine/wash tank and thick dust on pipes/ceilings above food packaging and processing areas. 5. **Contamination Risks:** Openings in ceilings, corroded fans directly over product, flaking paint on walls near uncovered sprouts, and dust on walls/ceilings/seed coverings in storage warehouses.

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