There was one company in the City of St. Louis that received FDA citations as a result of one inspection conducted in the city over the second quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous quarter.
The citations in the city were ‘The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830’ and ‘The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820’.
The company cited should take a voluntary action to correct its managing operations.
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Triumph Pharmaceuticals, Inc. | Devices | 04/29/2025 | Label to bear a unique device identifier |
| Triumph Pharmaceuticals, Inc. | Devices | 04/29/2025 | Lack of or inadequate organizational structure |
