Whitewater Times

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

This is a 150% increase over the number of companies cited in the previous year.

The citations in the county include:

• Procedures to control environmental conditions have not been adequately established.
• A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
• Procedures for corrective and preventive action have not been adequately established.

Most of the companies cited were involved in either Veterinary or Food and Cosmetics sectors.

Of the companies cited, four should take voluntary actions to correct their managing operations (80%). Additionally, one company had to take regulatory and/or administrative actions (20%).

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
Merry-Water Farms, Inc.	Veterinary	07/19/2023	Introduction/delivery into IS - illegal drug residue
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
Preservation Solutions, Inc.	Devices	07/14/2023	Environmental control Lack of or inadequate procedures
Preservation Solutions, Inc.	Devices	07/14/2023	Lack of or inadequate process validation
Preservation Solutions, Inc.	Devices	07/14/2023	Lack of or inadequate procedures
York Dairy	Veterinary	10/17/2023	ELDU - producer causes Illegal drug residue
York Dairy	Veterinary	10/17/2023	Record keeping