FDA WARNING_LETTER - Soterion Development, Inc. - May 21, 2019

On August 19, 2019, the FDA issued a Warning Letter to Soterion Development, Inc. following an inspection on May 20-21, 2019, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's response on June 6, 2019, was deemed inadequate as it did not address the FDA-483 observations.

The FDA found the firm's scombrotoxin-forming fish (Yellowfin tuna and Mahi-mahi) to be adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key violations included:

1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The "HACCP plan for Histamine-Producing Species" failed to list storage as a critical control point for scombrotoxin formation, despite storing fish for up to (b)(4) hours. The FDA recommends continuous icing or holding at 40°F (4.4°C) during storage, even for same-day shipments exceeding four hours from receipt to shipping.

2. **Inadequate Critical Limits (21 CFR 123.6(c)(3