St. Louis Reporter

There were seven companies in the City of St. Louis that received FDA citations as a result of seven inspections conducted in the city throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 22.2% decrease from the number of companies cited in the previous year.

Of the 27 citations issued, the most common citations were 'Procedures for corrective and preventive action have not been adequately established' and 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established'.

Most of the companies cited were involved in either Food and Cosmetics or Devices sectors.

Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).

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
Allied Medical, LLC	Devices	11/08/2023	Individual Report of Malfunction
Allied Medical, LLC	Devices	11/08/2023	Training - Lack of or inadequate procedures
Allied Medical, LLC	Devices	11/08/2023	Purchasing controls, Lack of or inadequate procedures
Allied Medical, LLC	Devices	11/08/2023	Contamination control, Lack of or inadequate procedures
Allied Medical, LLC	Devices	11/08/2023	Lack of or inadequate procedures
Allied Medical, LLC	Devices	11/08/2023	Lack of or inadequate complaint procedures
Allied Medical, LLC	Devices	11/08/2023	Service reports
SSM-SLUH, Inc.	Biologics	02/17/2023	Written record not kept of program and validation data
SSM-SLUH, Inc.	Biologics	02/17/2023	Written record of investigation incomplete
SSM-SLUH, Inc.	Biologics	02/17/2023	Establish, maintain and follow manufacturing SOPs
TJ's Pizza Company	Food and Cosmetics	08/02/2023	Manufacturing, processing, packing, holding - Controls
TJ's Pizza Company	Food and Cosmetics	08/02/2023	Food safety plan
Triumph Pharmaceuticals, Inc.	Devices	01/19/2023	Lack of Written MDR Procedures
Triumph Pharmaceuticals, Inc.	Devices	01/19/2023	Documented evaluation
Triumph Pharmaceuticals, Inc.	Devices	01/19/2023	Lack of or inadequate procedures
Triumph Pharmaceuticals, Inc.	Devices	01/19/2023	DMR - not or inadequately maintained
Triumph Pharmaceuticals, Inc.	Devices	01/19/2023	Lack of or inadequate complaint procedures
True Sun Trading, Inc.	Food and Cosmetics	04/26/2023	Develop FSVP
True Sun Trading, Inc.	Food and Cosmetics	04/26/2023	Identification - entry
Veran Medical Technologies, Inc.	Devices	02/23/2023	Report of Death or Serious Injury
Veran Medical Technologies, Inc.	Devices	02/23/2023	Process changes - review, evaluation and revalidation
Veran Medical Technologies, Inc.	Devices	02/23/2023	Lack of or inadequate procedures
Veran Medical Technologies, Inc.	Devices	02/23/2023	Investigation of device failures
Wan-Gee Foods, Inc.	Food and Cosmetics	05/24/2023	Personnel
Wan-Gee Foods, Inc.	Food and Cosmetics	05/24/2023	Equipment and utensils - Design and maintenance
Wan-Gee Foods, Inc.	Food and Cosmetics	05/24/2023	Manufacturing, processing, packing, holding - Controls
Wan-Gee Foods, Inc.	Food and Cosmetics	05/24/2023	Other Preventive Controls - Appropriate (Adequate)