FDA WARNING_LETTER - E and M Bakery, Inc. - June 10, 2011

The FDA inspected E and M Bakery, Inc.'s seafood processing facility from June 6-10, 2011, and again from July 14-21, 2011, due to an initial environmental sample testing positive for *Listeria monocytogenes*. A follow-up inspection confirmed *L. monocytogenes* in a multigrain tuna salad sandwich, rendering it adulterated under 21 U.S.C. § 342(a)(1). Environmental samples also confirmed *L. monocytogenes* on a baking room tabletop and a floor drain, indicating insanitary conditions under 21 U.S.C. § 342(a)(4).

The facility also violated seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Significant violations included insufficient monitoring of sanitation conditions (21 CFR 123.11(b)), evidenced by live flies on food and surfaces, food items stored directly against walls in coolers, and condensate dripping onto food. Additionally, the firm's HACCP plan for Tuna Sandwiches failed to list scombrotoxin (histamine) formation as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)).

The FDA requires