FDA WARNING_LETTER - St. Louis Calco, LLC - September 29, 2023

The FDA inspected St. Louis Calco, LLC's sprout operation in Fenton, MO, from September 18-22 and September 29, 2023, revealing serious violations of the Produce Safety Regulation (21 CFR Part 112). The mung bean and soybean sprout products are deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **No Environmental Monitoring Plan (21 CFR 112.145):** The firm lacked a written plan for *Listeria* species or *Listeria monocytogenes* (L. monocytogenes) environmental monitoring, a repeat observation from a 2019 inspection. FDA samples identified L. monocytogenes in 4 of 102 environmental swabs, including food contact surfaces. The firm's post-cleaning samples were deemed insufficient. 2. **Inadequate Sprout Irrigation Water/In-Process Sprout Sampling Plan (21 CFR 112.144(b), 112.147):** The firm did not have a written sampling plan for spent sprout irrigation water (SSIW) or in-process sprouts for each production batch, another repeat violation. Samples were not representative of each batch, and there was no evidence of holding sprouts pending negative pathogen test results. 3