Central STL News

There were four companies in cities associated with St. Louis County that received FDA citations as a result of four inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% decrease from the number of companies cited in the previous year.

The citations in the county include:

• You did not make and keep records of a material review and disposition decision on a returned dietary supplement.
• You did not develop an FSVP.
• A device master record has not been adequately maintained.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
M & L Trading, Inc.	Food and Cosmetics	04/06/2023	Develop FSVP
National Dentex, LLC	Devices	03/17/2023	DMR - not or inadequately maintained
National Dentex, LLC	Devices	03/17/2023	Lack of or inadequate DHR procedures
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Training content requirements
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Training for supervisors
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Ag. water - E.coli standard
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Equip & tools - cleanability
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Equip & tools - storage
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Non-food-contact surface maintenance and cleaning
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Buildings - prevent contamination
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Toilet servicing
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Hand-washing facility proximity
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Sanitary food contact surfaces
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Written environmental monitoring plan
St. Louis Calco, LLC	Food and Cosmetics	09/29/2023	Written sampling plan for spent irrigation water or sprouts
ZeaVision Holdings, Inc.	Food and Cosmetics	05/18/2023	Records - ret'nd dietary supplement: material review, dispos