NE Ohio Times

There was one company in a city associated with Geauga County that received FDA citations as a result of one inspection conducted in the county over the third 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:

• Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
• The type and extent of control to be exercised over services and suppliers was not clearly defined.
• Products that do not conform to specifications are not adequately controlled.

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
Troy Innovative Instruments, Inc.	Devices	07/26/2024	Management review - defined interval, sufficient frequency
Troy Innovative Instruments, Inc.	Devices	07/26/2024	Supplier oversight
Troy Innovative Instruments, Inc.	Devices	07/26/2024	Nonconforming product control
Troy Innovative Instruments, Inc.	Devices	07/26/2024	Documentation
Troy Innovative Instruments, Inc.	Devices	07/26/2024	Complaints