The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters.
Warning letters often are not issued until a company has been given months to years to correct problems. St. Louis Calco LLC Fenton, MO The U.
S. Food and Drug Administration has issued a warning letter to St. Louis Calco LLC, a Fenton, MO-based sprout operation, after finding serious violations of federal food safety regulations.
The letter, dated March 21, 2024, follows FDA inspection conducted from Sept. 18-22, 2023, and Sept. 29, 2023, which revealed multiple violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, commonly known as the Produce Safety Rule (PSR).
St. Louis Calco LLC produces mung bean and soybean sprouts, which the FDA has deemed adulterated. According to the FDA, the sprouts were prepared, packed, or held under unsanitary conditions, potentially exposing consumers to harmful contaminants.
The inspection also revealed that the company failed to comply with the PSR. The inspection resulted in the issuance of a Form FDA 483. The letter highlights several specific issues that were uncovered during the inspection.
Lack of listeria monitoring plan The FDA noted that St. Louis Calco has not implemented a written environmental monitor.
