Racine Sun

There was one company in a city associated with Racine County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

• Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.
• Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system.
• Procedures for quality audits have not been 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.

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
Daniels Manufacturing Operations, Inc.	Devices	11/08/2023	Management ensuring quality policy is understood
Daniels Manufacturing Operations, Inc.	Devices	11/08/2023	Management review - defined interval, sufficient frequency
Daniels Manufacturing Operations, Inc.	Devices	11/08/2023	Quality audits - Lack of or inadequate procedures
Daniels Manufacturing Operations, Inc.	Devices	11/08/2023	Procedures not adequately established or maintained
Daniels Manufacturing Operations, Inc.	Devices	11/08/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Daniels Manufacturing Operations, Inc.	Devices	11/08/2023	Documentation