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 third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 50% decrease from the number of companies cited in the previous quarter.
The citations in the city include:
- 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.
- Procedures for design control have not been established.
- Procedures to ensure equipment is routinely calibrated have not been adequately established.
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.
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 |
|---|---|---|---|
| Apollo Megasun, LLC | Devices | 08/29/2024 | Label to bear a unique device identifier |
| Apollo Megasun, LLC | Devices | 08/29/2024 | Design control – no procedures |
| Apollo Megasun, LLC | Devices | 08/29/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Apollo Megasun, LLC | Devices | 08/29/2024 | Lack of or inadequate final acceptance procedures |
