WC Indiana News

There were two companies in a city associated with Vigo County that received FDA citations as a result of two inspections conducted in the county throughout 2023, 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 year.

The citations in the county include:

• You did not exclude pests from your food plant to protect against contamination of food.
• You did not store or transport a food under conditions that protect against contamination.
• No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.

The companies cited were involved in either Food and Cosmetics or Devices sectors.

Both 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
Flowers Baking Company of Bardstown KY, LLC	Food and Cosmetics	09/22/2023	Pest control
Flowers Baking Company of Bardstown KY, LLC	Food and Cosmetics	09/22/2023	Storage and Distribution
Johns Dental Laboratories, Inc.	Devices	07/14/2023	Management representative
Johns Dental Laboratories, Inc.	Devices	07/14/2023	Quality Audits - defined intervals
Johns Dental Laboratories, Inc.	Devices	07/14/2023	Design history file
Johns Dental Laboratories, Inc.	Devices	07/14/2023	Process control procedures, Lack of or inadequate procedures
Johns Dental Laboratories, Inc.	Devices	07/14/2023	Lack of or inadequate procedures
Johns Dental Laboratories, Inc.	Devices	07/14/2023	Lack of or inadequate DHR procedures
Johns Dental Laboratories, Inc.	Devices	07/14/2023	Lack of or inadequate complaint procedures