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) |
