Racine Sun

There were three companies in cities associated with Racine County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% increase over the number of companies cited in the previous year.

The citations in the county include:

• You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with current good manufacturing practice including prevention of cross-contamination from insanitary objects, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals and exclusion of pests.
• Your written hazard analysis does not consist of a review of your current process to determine whether modifications are necessary.
• You did not implement the monitoring and verification procedures listed in your HACCP plan.

Most of the companies cited were involved in the Food and Cosmetics sector.

All of the 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
Brightonwoods Orchard, Inc.	Food and Cosmetics	09/28/2023	Sanitation monitoring
Brightonwoods Orchard, Inc.	Food and Cosmetics	09/28/2023	Hazard analysis - written - elements
Brightonwoods Orchard, Inc.	Food and Cosmetics	09/28/2023	HACCP plan not implemented
Brightonwoods Orchard, Inc.	Food and Cosmetics	09/28/2023	HACCP plan - critical control points not listed
Brightonwoods Orchard, Inc.	Food and Cosmetics	09/28/2023	Corrective action - predetermined plan
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
Nestle USA, Inc.	Food and Cosmetics	02/16/2023	Plant construction and design
Nestle USA, Inc.	Food and Cosmetics	02/16/2023	Pest control
Nestle USA, Inc.	Food and Cosmetics	02/16/2023	Equipment and utensils - Design and maintenance
Nestle USA, Inc.	Food and Cosmetics	02/16/2023	Hazard analysis - Identification of hazard
Nestle USA, Inc.	Food and Cosmetics	02/16/2023	Process preventive controls - Implement