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

Source: https://www.globalkeysolutions.net/records/warning_letter/missa-bay-llc/a0ae5b3e-a781-47cd-ba8b-c2ecae50ce52

> FDA WARNING_LETTER for Missa Bay, LLC on August 23, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Missa Bay, LLC
- Inspection Date: 2012-08-23
- Product Type: Food
- Office Name: Department of Health and Human Services
- Summary: 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

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/diana-amador-toro/66f3f6c5-4cfe-4f40-b4d4-d24ed4618e64)

Company: https://www.globalkeysolutions.net/companies/missa-bay-llc/fdf0267d-63ee-4bf0-b6a3-f2fb703e8bf0

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861