FDA WARNING_LETTER - Societe Nouvelle Averio Maroc - October 06, 2009

On October 5-6, 2009, the FDA inspected Societe Nouvelle Averio Maroc's canned seafood facility in Agadir, Morocco, identifying serious violations of the U.S. Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123). These violations render their canned sardines adulterated under Section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act. While the firm's October 12, 2009, response adequately addressed low-acid canned food regulations (21 CFR 108 and 113), significant deviations from seafood HACCP requirements remain.

Key violations include: 1. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan for "Canned Sardine and Mackerel" lacks adequate critical limits to control scombrotoxin (histamine) formation. Specifically, it doesn't include monitoring internal fish temperatures upon off-loading from vessels, and the "Presence of ice" critical limit at reception is insufficient, as observed fish temperatures were 11.6°C (52.9°F) with inadequate ice. 2. **Inadequate Monitoring Procedures (21 CFR 123.6(c)(4)):** The plan's monitoring procedure for histamine testing at the "Reception"