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

Source: https://www.globalkeysolutions.net/records/warning_letter/st-louis-calco-llc/bce22b1c-262a-4100-a567-11a14539a178

> FDA WARNING_LETTER for St. Louis Calco, LLC on September 29, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: St. Louis Calco, LLC
- Inspection Date: 2023-09-29
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.
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## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)

Company: https://www.globalkeysolutions.net/companies/st-louis-calco-llc/16da3ec8-bb3b-4ec1-9fc1-a5f786239f1d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8