FDA WARNING_LETTER - Sanuki Kanzume Co - November 19, 2010

On November 18-19, 2010, the FDA inspected Sanuki Kanzume Co.'s low-acid canned food facility in Japan, identifying serious deviations from 21 CFR Parts 108 and 113. These failures render products adulterated under Section 402(a)(4) of the Act, potentially leading to emergency permit control provisions (21 CFR 108.25(j)) and import refusal.

The inspection resulted in an FDA-483, and the firm's November 30, 2010, response was deemed inadequate. Remaining concerns include: * **Unsubstantiated Process Change (21 CFR 108.35(c)(2)(ii)):** Processing "Mushrooms Nameko (Whole) in Water Salt Added: Nameko Mizuni" in an unlisted can size. A revised process filing, including critical venting times and temperatures (21 CFR 114.100(a)(1)), is required but not received. * **Failure to Record Initial Temperature (21 CFR 113.87(c)):** Not measuring initial temperatures for Nameko Mizuni mushrooms. No documented evidence of new monitoring procedures was provided. * **Retort Bleeder Deficiency (21 CFR 113.40(a)(2)):** Vertical still ret