Orlando Standard

There were three companies in cities associated with Orange County that received FDA citations as a result of three 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 a 50% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
• Your quality control personnel did not reject a component for which a specification was not met.
• You did not follow written procedures for the requirements for components of dietary supplements.

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
CEMI International, Inc.	Food and Cosmetics	11/03/2023	Component - verify identity, dietary ingredient
CEMI International, Inc.	Food and Cosmetics	11/03/2023	Specifications not met - reject, quality control
CEMI International, Inc.	Food and Cosmetics	11/03/2023	Written procedures - components
Hevener Sales, Inc.	Food and Cosmetics	10/24/2023	Develop FSVP
Optimotion Implants, LLC	Devices	10/20/2023	Product rework adverse effects {see also 820.184}