Shelby Reporter

There were nine companies in cities associated with Shelby County that received FDA citations as a result of nine inspections conducted in the county throughout 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 year.

The citations in the county include:

• Required records are not stored to minimize deterioration and prevent loss and are not backed up when stored in automated data processing systems.
• Records of complaint investigations do not include required information.
• Procedures for corrective and preventive action have not been adequately established.

Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the the Food and Cosmetics sector.

Of the companies cited, seven should take voluntary actions to correct their managing operations (77.8%). Additionally, two companies had to take regulatory and/or administrative actions (22.2%).

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
AB Mauri Foods, Inc.	Food and Cosmetics	02/10/2023	Personnel
AB Mauri Foods, Inc.	Food and Cosmetics	02/10/2023	Plant construction and design
AB Mauri Foods, Inc.	Food and Cosmetics	02/10/2023	Sanitary operations - Plant maintenance
AB Mauri Foods, Inc.	Food and Cosmetics	02/10/2023	Equipment and utensils - Design and maintenance
AB Mauri Foods, Inc.	Food and Cosmetics	02/10/2023	Process preventive controls - Appropriate (Adequate)
CE-Bio, LLC	Food and Cosmetics	12/06/2023	In-process identity, purity, strength, composition
CE-Bio, LLC	Food and Cosmetics	12/06/2023	Specifications - labels, packaging
CE-Bio, LLC	Food and Cosmetics	12/06/2023	Specifications - identity, purity, strength, composition
CE-Bio, LLC	Food and Cosmetics	12/06/2023	Quality control - dietary supplement; adulteration
CE-Bio, LLC	Food and Cosmetics	12/06/2023	Batch record - complete
Central States Foods, Inc.	Food and Cosmetics	05/25/2023	Toxic chemicals - Identified, held, stored
Cornerstone Laboratories, LLC	Drugs	01/19/2023	Procedures not in writing, fully followed
Cornerstone Laboratories, LLC	Drugs	01/19/2023	Training--operations, GMPs, written procedures
Cornerstone Laboratories, LLC	Drugs	01/19/2023	Computer control of master formula records
Cornerstone Laboratories, LLC	Drugs	01/19/2023	Calibration - at intervals, written program, remedial action
Cornerstone Laboratories, LLC	Drugs	01/19/2023	Complete Test Data
Edge Biologicals, Inc.	Devices	04/04/2023	Quality Audits - defined intervals
Edge Biologicals, Inc.	Devices	04/04/2023	Personnel
Edge Biologicals, Inc.	Devices	04/04/2023	Evaluation of suppliers, contractors, etc., requirements
Edge Biologicals, Inc.	Devices	04/04/2023	Environmental control Lack of or inadequate procedures
Edge Biologicals, Inc.	Devices	04/04/2023	Lack of or inadequate process validation
Edge Biologicals, Inc.	Devices	04/04/2023	Lack of or inadequate procedures - Acceptance activities
Edge Biologicals, Inc.	Devices	04/04/2023	Lack of or inadequate procedures
Edge Biologicals, Inc.	Devices	04/04/2023	DMR - not or inadequately maintained
Engineered Medical Systems, LLC	Devices	02/10/2023	Lack of or inadequate procedures
Matrix Machining Technologies, Inc.	Devices	01/26/2023	Quality audits - Lack of or inadequate procedures
Matrix Machining Technologies, Inc.	Devices	01/26/2023	Training - Lack of or inadequate procedures
Odyssey Medical Technologies, LLC.	Devices	04/03/2023	Records of complaint investigation
Somavac Medical Solutions, Inc.	Devices	09/22/2023	Availability