FDA WARNING_LETTER - SSE Manufacturing, Inc - December 10, 2013

The FDA inspected SSE Manufacturing, Inc. (Schwan’s Global Supply Chain, Inc.) in Deer Park, Texas, from November 13 to December 10, 2013, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their shrimp egg roll and crab rangoon products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(1)):** The revised HACCP plan for shrimp egg rolls and crab rangoon does not list undeclared sulfiting agents in shrimp as a food safety hazard, despite their potential for severe reactions. The FDA recommends identifying sulfites as a hazard, including a critical control point at receiving with monitoring procedures for labels, and quarterly testing for sulfiting agents. Separate HACCP plans for shrimp egg rolls and crab rangoon are also recommended due to differing hazards. 2. **Insufficient Critical Limits (21 CFR 123.6(c)(3)):** The cook step critical limit of "(b)(4) degrees for (b)(4) seconds" is inadequate to ensure proper heat processing for bacterial pathogen control (e.g., 6D thermal lethality for *