Utah Valley Times

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

This is a 20% decrease from the number of companies cited in the previous year.

Of the 21 citations issued, the most common citations include:

• You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.
• You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
• You did not establish component specifications for strength.

Most of the companies cited were involved in the Food and Cosmetics 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
American Crafts	Food and Cosmetics	02/28/2023	Develop FSVP
Aspen Company-Pak, LLC	Food and Cosmetics	08/02/2023	Specifications - identity, purity, strength, composition
Aspen Company-Pak, LLC	Food and Cosmetics	08/02/2023	Component - verify identity, dietary ingredient
Aspen Company-Pak, LLC	Food and Cosmetics	08/02/2023	Records - date; review, approval, rejection
Aspen Company-Pak, LLC	Food and Cosmetics	08/02/2023	Label, packaging - discrepancies
Nature's Energy	Food and Cosmetics	05/15/2023	Specifications-component purity, strength, composition
Nature's Energy	Food and Cosmetics	05/15/2023	Tests, examinations - scientifically valid
Pharmatech, Inc.	Food and Cosmetics	08/09/2023	Registration
Pharmatech, Inc.	Food and Cosmetics	08/09/2023	Process filing
Pharmatech, Inc.	Food and Cosmetics	08/09/2023	Specifications - contamination limits
Pharmatech, Inc.	Food and Cosmetics	08/09/2023	Component - verify identity, dietary ingredient
Pharmatech, Inc.	Food and Cosmetics	08/09/2023	Component - certificate of analysis
SteriGear, LLC	Devices	03/22/2023	Purchasing controls, Lack of or inadequate procedures
SteriGear, LLC	Devices	03/22/2023	Investigation of device failures
SupraNaturals, LLC	Food and Cosmetics	08/02/2023	Specifications-component purity, strength, composition
SupraNaturals, LLC	Food and Cosmetics	08/02/2023	Specifications - contamination limits
SupraNaturals, LLC	Food and Cosmetics	08/02/2023	Specifications identity, purity strength, composition
TruVision Health, LLC	Food and Cosmetics	04/17/2023	Quality control - reject; specification not met
TruVision Health, LLC	Food and Cosmetics	04/17/2023	Records - ret'nd dietary supplement: material review, dispos
TruVision Health, LLC	Food and Cosmetics	04/17/2023	Written procedures - product complaint
Utah Valley Hospital	Biologics	10/06/2023	Person performing, test results, interpretation