St. Charles Times

There were two companies in cities associated with St. Charles County that received FDA citations as a result of two inspections 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:

• Records of acceptable suppliers have not been adequately established.
• Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
• A validated process was not revalidated when changes or process deviations occurred.

Both companies cited should take voluntary actions to correct their 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
DynaFlex	Devices	09/25/2023	Acceptable supplier records, inadequate records
DynaFlex	Devices	09/25/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
DynaFlex	Devices	09/25/2023	Process changes - review, evaluation and revalidation
DynaFlex	Devices	09/25/2023	Lack of or inadequate complaint procedures
Vortex Surgical, Inc.	Devices	02/09/2023	Lack of or inadequate process validation