Sarasota Review

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

This is a 66.7% decrease from the number of companies cited in the previous year.

The citations in the county include:

• Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.
• Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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
Global Health Naturals Nutritional Supplements, LLC	Food and Cosmetics	08/04/2023	Contact surfaces - not in direct contact - cleaning
Global Health Naturals Nutritional Supplements, LLC	Food and Cosmetics	08/04/2023	Document - required operation
Omeza, LLC	Drugs	07/28/2023	Sanitation--buildings not clean, free of infestation
Omeza, LLC	Drugs	07/28/2023	Written procedures not established/followed
Omeza, LLC	Drugs	07/28/2023	Reports of Analysis (Components)
Omeza, LLC	Drugs	07/28/2023	Testing and release for distribution
Omeza, LLC	Drugs	07/28/2023	Written program not followed
Omeza, LLC	Drugs	07/28/2023	Complete instructions, procedures, specifications et. al.
Vitality Products International, LLC	Food and Cosmetics	11/08/2023	Written procedures - holding
Vitality Products International, LLC	Food and Cosmetics	11/08/2023	Written procedures - returned dietary supplement
Vitality Products International, LLC	Food and Cosmetics	11/08/2023	Written procedures - product complaint