There was one company in a city associated with Pierce County that received FDA citations as a result of one inspection conducted in the county in October, according to the U.S. Food and Drug Administration (FDA).
No companies were cited in the previous month.
The citations in the county 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.
- The design history file was not established.
- A device history record has not been maintained.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Safer Medical Products, Inc. | Devices | 10/08/2025 | Label to bear a unique device identifier |
| Safer Medical Products, Inc. | Devices | 10/08/2025 | Design history file |
| Safer Medical Products, Inc. | Devices | 10/08/2025 | DHR – not or inadequately maintained |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
