Mitsutoyo Co. Ltd., Hakodate Plant – FDA Warning Letter, Nov 16, 2012

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