# FDA WARNING_LETTER - Sanuki Kanzume Co - November 19, 2010

Source: https://www.keypedia.com/records/warning_letter/sanuki-kanzume-co/4ea3abe3-e3a1-4974-b9b0-eeada9450ede

> FDA WARNING_LETTER for Sanuki Kanzume Co on November 19, 2010. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sanuki Kanzume Co
- Inspection Date: 2010-11-19
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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

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Company: https://www.keypedia.com/companies/sanuki-kanzume-co/3133f837-a521-4e77-87fe-5514c5fe0c50

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2