Metro East Sun

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 over the second quarter of 2024, 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 quarter.

The citations in the county include:

• Your personnel did not remove unsecured jewelry that might fall into components, dietary supplements, equipment, or packaging.
• You did not written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.
• You did not have records or copies of records required for components readily available during the required retention period for inspection and copying by FDA when requested.

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
Genetidyne	Food and Cosmetics	04/02/2024	Jewelry and objects - remove
Genetidyne	Food and Cosmetics	04/02/2024	Procedures - calibrating automated, mechanical equip
Genetidyne	Food and Cosmetics	04/02/2024	Records - comp, package, labels, product received: Available
Genetidyne	Food and Cosmetics	04/02/2024	Batch record - complete
Genetidyne	Food and Cosmetics	04/02/2024	Batch record - manufacture