St. Louis Calco, LLC

Warning LetterOpen

Mr. Xiaohui Zhou Owner St. Louis Calco, LLC 1336 W. Lark Industrial Dr. Fenton , MO 63026-4323 United StatesFEI 1937592Issued Mar 21, 2024Division of Human and Animal Food Operations West II

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1937592.

Violations7

Issue DateMar 21, 2024

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: St. Louis Calco, LLC
Location: Mr. Xiaohui Zhou Owner St. Louis Calco, LLC 1336 W. Lark Industrial Dr. Fenton , MO 63026-4323 United States
FEI Number: 1937592
Country: United States
Issue Date: March 21, 2024
Issuing Office: Division of Human and Animal Food Operations West II
Product Type: Food & Beverages
Status: Open

Summary

St. Louis Calco, LLC, a sprout producer in Fenton, Missouri, manufactured mung bean and soybean sprout products under insanitary conditions, rendering them adulterated and potentially contaminated with filth or harmful substances. During FDA inspections in September 2023, investigators identified serious violations of the Produce Safety Regulation (21 CFR Part 112), including the company's failure to establish and implement a written environmental monitoring plan designed to detect Listeria species or Listeria monocytogenes in its growing, harvesting, packing, and holding environment. This represented a repeat violation, as the same deficiency had been observed during a previous inspection of the firm.

St. Louis Calco, LLC FDA Warning Letter, March 21, 2024