Treasure Coast Sun

There was one company in a city associated with St. Lucie County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• Each supervisor you use is not qualified by education, training, or experience to supervise.
• You did not establish and follow written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.
• You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.

The company cited was involved in the Food and Cosmetics sector.

The company cited should take a voluntary action to correct its 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
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Supervisor - education, training
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Procedures - calibrating automated, mechanical equip
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Component - verify identity, dietary ingredient
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Specifications met - test, examinations; compliance
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Reserve sample - retained
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Reserve sample - twice the quantity
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Written procedures - quality control operations
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Written procedures - rejected components, packaging, labels
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Master manufacturing record - each batch
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Batch record - complete
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Batch record - date, time; maintenance
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Batch record - specifications
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Batch record - label
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Written procedures - labeling operations
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Written procedures - holding; distributing
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Product complaint - quality control review
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Code - required elements
Lipo Naturals, LLC	Food and Cosmetics	07/18/2023	Cleaning and sanitizing substances - Safe and adequate