East Volusia News

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

This is a 33.3% increase over the number of companies cited in the previous year.

The citations in the county include:

• An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
• The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Input to and output from the computer and records or data are not checked for accuracy.

Most of the companies cited were involved in the Drugs 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
Balassa Laboratories, Inc.	Drugs	04/07/2023	Handling and Storage to Prevent Contamination
Balassa Laboratories, Inc.	Drugs	04/07/2023	Identification of containers, lines, equipment
Balassa Laboratories, Inc.	Drugs	04/07/2023	Control procedures to monitor and validate performance
Command Medical Products, Inc.	Devices	08/08/2023	Personnel requirements, Lack of or inadequate requirements
Dr. Bruce G. Rankin, DO	Drugs	09/22/2023	FD-1572, protocol compliance
Playtex Manufacturing, Inc.	Drugs	04/19/2023	Procedures not in writing, fully followed
Playtex Manufacturing, Inc.	Drugs	04/19/2023	input/output verification
Playtex Manufacturing, Inc.	Drugs	04/19/2023	Written Procedures Not Followed
Playtex Manufacturing, Inc.	Drugs	04/19/2023	Written record of investigation incomplete