North Utah News

There were two companies in a city associated with Cache County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 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 quarter.

The citations in the county include:

• An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
• Corrective and preventive action activities and/or results have not been adequately documented.
• Complaint files are not adequately maintained.

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
OsteoCentric Technologies, Inc.	Devices	11/13/2023	Report of Death or Serious Injury
OsteoCentric Technologies, Inc.	Devices	11/13/2023	Documentation
OsteoCentric Technologies, Inc.	Devices	11/13/2023	Complaints
Zollingers Fruit & Tree Farm, Inc.	Food and Cosmetics	11/09/2023	Hazard analysis - written - elements