FDA WARNING_LETTER - Missa Bay, LLC - August 23, 2012

The FDA inspected Missa Bay, LLC's facility in Swedesboro, NJ, from July 27 to August 23, 2012, following a report of *Listeria monocytogenes* (Lm) in apple slices. The inspection found finished product samples of diced and sliced apples positive for Lm, rendering them adulterated under 21 U.S.C. § 342(a)(1).

Additionally, Lm was detected on food contact surfaces, non-food contact surfaces, and in ascorbic acid dip solution within the apple processing room. A total of 27 Lm environmental subsamples yielded Lm, with isolates indistinguishable from those in finished product samples by PFGE analysis. This indicates cross-contamination and harborage issues, leading to adulteration under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Missa Bay voluntarily recalled apple products produced between July 8 and August 20, 2012, and ceased apple production at the Swedesboro location. Their September 5, 2012, response mentioned developing a redesigned Listeria Control and Monitoring Program and abandoning a specific piece of equipment for a new process, but lacked details, supporting documentation, or efficacy data for the new process. The company identified a " (b)(4) " as the source of contamination but did not detail corrective actions