FDA WARNING_LETTER - Balfego and Balfego, SL - April 08, 2014

The FDA issued a Warning Letter to Balfego and Balfego, S.L. following an April 7-8, 2014 inspection and subsequent review of their revised HACCP plan for sashimi grade Bluefin tuna. The FDA found the firm's responses and revised HACCP plan, dated August 18, 2014, inadequate, rendering their Bluefin tuna adulterated under 21 U.S.C. § 342(a)(4) due to preparation, packing, or holding conditions that may render it injurious to health.

Significant deviations from 21 CFR Part 123 were identified: 1. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** * **Receiving and Unloading:** Critical limits for histamine formation control were insufficient, lacking comprehensive harvest vessel record, sensory examination, and internal temperature monitoring components for both harvest vessel record and histamine testing strategies. * **Transit:** Critical limits for histamine formation during transit were inadequate, failing to ensure proper temperatures throughout the entire transit period. * **Unrefrigerated Processing:** Critical limits for histamine formation and pathogen growth/toxin formation during unrefrigerated processing were inadequate, as they did not include maximum cumulative time of exposure.

2. **Inadequate Monitoring Procedures and Frequency (21 CFR 123.6(c)(