Thumb Reporter

There was one company in a city associated with St. Clair County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• Procedures for training and identifying training needs have not been adequately established.
• The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements 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
Signal Medical Corporation	Devices	04/10/2023	Training - Lack of or inadequate procedures
Signal Medical Corporation	Devices	04/10/2023	Design history file
Signal Medical Corporation	Devices	04/10/2023	Purchasing controls, Lack of or inadequate procedures
Signal Medical Corporation	Devices	04/10/2023	Statistical techniques - Lack of or inadequate procedures