Ito En (USA) Inc. – FDA Warning Letter, Jul 2, 2012

On November 2, 2012, the FDA issued a Warning Letter to Ito En (USA) Inc. following an inspection of their Honolulu, Hawaii low-acid canned food facility from June 25-28 and July 2, 2012. The inspection revealed serious deviations from low-acid canned food regulations (21 CFR Parts 108 and 113), which could lead to products being deemed adulterated under Sections 402(a)(3) and 402(a)(4) of the Act.

Key violations included: 1. **Failure to adhere to scheduled processes (21 CFR 108.35(c)(3)(i)):** The firm's Iced Cappuccino and Green Tea products were processed with times shorter than the minimum process times filed with the FDA. The company's response indicated a review by their process authority and a plan to log deviations and hold affected products, which the FDA stated would be verified in a future inspection. 2. **Failure to sanitize cooling water (21 CFR 113.60(b)):** Records showed no detectable chlorine in recirculated cooling water on multiple dates. The company's response outlined a plan for daily chlorinator checks but lacked documented evidence of implementation. 3. **Failure to properly code containers (21 CFR 113.60(c)):**