NC Indiana News

There was one company in a city associated with Kosciusko County that received FDA citations as a result of one inspection conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 75% decrease from the number of companies cited in the previous year.

The citations in the county include:

• The equipment used in the manufacturing process does not meet specified requirements.
• Procedures for corrective and preventive action have not been adequately established.
• Procedures to ensure sampling methods are adequate for their intended use 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.

According to its website, 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Precision Medical Technologies, Inc.	Devices	09/06/2024	Equipment Installation, Placement, Specified Requirements
Precision Medical Technologies, Inc.	Devices	09/06/2024	Lack of or inadequate procedures
Precision Medical Technologies, Inc.	Devices	09/06/2024	Sampling methods - Lack of or inadequate procedures