# FDA WARNING_LETTER - Mitsutoyo Co. Ltd., Hakodate Plant - November 16, 2012

Source: https://www.keypedia.com/records/warning_letter/mitsutoyo-co-ltd-hakodate-plant/ee168cd4-df92-4a38-a2a5-e6e8189996a8

> FDA WARNING_LETTER for Mitsutoyo Co. Ltd., Hakodate Plant on November 16, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mitsutoyo Co. Ltd., Hakodate Plant
- Inspection Date: 2012-11-16
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to Mitsutoyo Co. Ltd. following an inspection of their Hakodate Plant in Japan on November 15-16, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123), rendering their frozen ready-to-eat prepared squid adulterated.

Despite the firm's December 14, 2012, response, which included a revised HACCP plan and processing records, the FDA identified continuing concerns. Key violations include:

1.  **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(c)(2)):** The revised HACCP plan for frozen, ready-to-eat prepared squid failed to list a critical control point for the primary aging step, which is crucial for controlling pathogen growth and toxin formation due to time and temperature abuse.

2.  **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The critical limits listed in the revised HACCP plan for the (b)(4) and (b)(4) critical control points were insufficient to control pathogen growth. The listed temperatures of (b)(4) and (b)(4) were deemed inadequate for extended holding periods, with FDA recommending temperatures of 40°F (4.4°C) or below, or holding on

## Related Officers

- [Roberta F. Wagner](https://www.keypedia.com/people/roberta-f-wagner/44ae7da7-afe0-4834-8b96-349a7b07ffbd)

Company: https://www.keypedia.com/companies/mitsutoyo-co-ltd-hakodate-plant/66a0c497-338a-4129-8146-0ae87ec9e0ce

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