Brevard Sun

There were two companies in cities associated with Brevard County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 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 quarter.

The citations in the county include:

• You did not establish procedures for holding and distributing operations.
• You did not establish written procedures for when a returned dietary supplement is received.
• Written MDR procedures have not been developed.

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
Han Tang Import & Export, Inc.	Food and Cosmetics	10/11/2023	Written procedures - holding
Han Tang Import & Export, Inc.	Food and Cosmetics	10/11/2023	Written procedures - returned dietary supplement
Wellness Without Limits, LLC	Devices	10/17/2023	Lack of Written MDR Procedures
Wellness Without Limits, LLC	Devices	10/17/2023	Lack of or inadequate procedures
Wellness Without Limits, LLC	Devices	10/17/2023	Lack of or inadequate complaint procedures