FDA WARNING_LETTER - Miyajima Shoyu Co., Ltd. - May 27, 2024

The FDA inspected a Japanese acidified food facility from May 24-27, 2024, identifying serious deviations from Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. The firm manufactures ready-to-eat, shelf-stable acidified dressings, including Wasabi Dressing exported to the U.S.

The primary violation is the failure to file scheduled processes for any acidified foods, including the Wasabi Dressing, as required by 21 CFR 108.25(c)(2). Additionally, the firm did not provide evidence that its scheduled process for Wasabi Dressing was established by a qualified person (21 CFR 114.83). Manufacturing records for Wasabi Dressing showed some pH values exceeding 4.5, and the addition of ambient temperature oil during filling may lower product temperature below an effective control point.

The FDA deems products adulterated if mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 are violated. The firm's response, stating they would cease U.S. exports, was deemed inadequate. The FDA recommends evaluating any Wasabi Dressing with pH > 4.6 for health risks and addressing the filling process's impact on product temperature.

The firm must notify the FDA within 15 working days of corrective actions, including preventing recurrence. Failure to