FDA WARNING_LETTER - Green Hope LLC dba Rosewood Products - March 16, 2011

On February 28 through March 16, 2011, the FDA inspected Green Hope, LLC dba Rosewood in Ann Arbor, MI, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations included: 1. **Hygienic Practices (21 CFR 110.10(b)(9)):** Employees used mouths to siphon liquid from ready-to-eat tofu kettles with contaminated hoses, and bare arms contacted cooling tofu. 2. **Minimizing Contamination (21 CFR 110.80(b)(2)):** Scoops and strainers were rinsed near the floor, causing splash-back onto food-contact surfaces and into product, and equipment was reused without proper cleaning. 3. **Hand Washing (21 CFR 110.10(b)(3)):** Employees touched soiled equipment and then food/food-contact surfaces without washing hands. 4. **Outer Garments (21 CFR 110.10(b)(1)):** An employee's apron contacted a waste container and then tofu pressing equipment. 5. **Cleaning and Sanitizing (21 CFR 110.35(a