FDA WARNING_LETTER - U.F. Union International Food Company - July 24, 2009

The FDA conducted an inspection of U.F. Union International Food Company, Inc.'s spice processing facility from March 27 to July 24, 2009, revealing significant violations. The inspection confirmed that white pepper products were adulterated under 21 U.S.C. § 342(a)(1) due to contamination with Salmonella enterica subsp. enterica serovar Rissen (S. rissen), a pathogenic microorganism. FDA analysis of finished product samples confirmed S. rissen presence. Furthermore, environmental samples from fourteen processing locations, including the white pepper grinding room, also tested positive for S. rissen with an indistinguishable genetic pattern, indicating the organism had established niche environments within the facility. Consequently, the firm's products were also deemed adulterated under 21 U.S.C. § 342(a)(4) for being prepared, packed, or held under insanitary conditions. Serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), including possible cross-contamination routes, were also identified. The firm initiated some corrections during the inspection, and post-inspection environmental swabs were negative. However, the FDA requires a written response within 15 working days detailing current corrective actions, specific steps taken, and supporting documentation to ensure lasting compliance and prevent recurrence, warning of potential regulatory actions like injunctions or seizures if violations persist.