Huntsville Leader

There were two companies in a city associated with Madison 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 a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

• Records of changes did not include a description of the change and identification of the affected documents.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
• Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.

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
Barksdale Dental Laboratory, Inc.	Devices	08/01/2023	Quality Audits - defined intervals
Barksdale Dental Laboratory, Inc.	Devices	08/01/2023	Equipment Installation, Placement, Specified Requirements
Barksdale Dental Laboratory, Inc.	Devices	08/01/2023	Documentation
Barksdale Dental Laboratory, Inc.	Devices	08/01/2023	Records of complaint investigation
Oral Arts Dental Laboratories, Inc.	Devices	08/04/2023	Change records, content
Oral Arts Dental Laboratories, Inc.	Devices	08/04/2023	Lack of or inadequate complaint procedures