Las Vegas City Wire

There were eight companies in cities associated with Clark 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 unchanged from the number of companies cited in the previous year.

Of the 26 citations issued, the most common citations were 'Your quality control operations did not include approving, and releasing from quarantine, all components before they were used' and 'You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement'.

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

Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).

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
DrVita, Inc.	Food and Cosmetics	05/25/2023	Specifications - contamination limits
DrVita, Inc.	Food and Cosmetics	05/25/2023	Master manufacturing record - controls, procedures
DrVita, Inc.	Food and Cosmetics	05/25/2023	Batch record - complete
DrVita, Inc.	Food and Cosmetics	05/25/2023	Tests, examinations - scientifically valid
Geneva Manufacturing, LLC	Food and Cosmetics	11/15/2023	Specifications - component identity
Geneva Manufacturing, LLC	Food and Cosmetics	11/15/2023	Specifications-component purity, strength, composition
Geneva Manufacturing, LLC	Food and Cosmetics	11/15/2023	Specifications - contamination limits
Geneva Manufacturing, LLC	Food and Cosmetics	11/15/2023	Specifications - identity, purity, strength, composition
Geneva Manufacturing, LLC	Food and Cosmetics	11/15/2023	Document - material review, disposition
Geneva Manufacturing, LLC	Food and Cosmetics	11/15/2023	Quality control operations - quarantine
Gramercy Bakery	Food and Cosmetics	10/13/2023	Plant operations - Precautions
Gramercy Bakery	Food and Cosmetics	10/13/2023	Storage and Distribution
Hard Eight Nutrition, LLC	Food and Cosmetics	10/04/2023	Quality control operations - quarantine
Hard Eight Nutrition, LLC	Food and Cosmetics	10/04/2023	Quality control operations - finished batch, specifications
Hard Eight Nutrition, LLC	Food and Cosmetics	10/04/2023	Sanitation preventive controls - Appropriate (Adequate)
Ken's Foods, Inc.	Food and Cosmetics	08/29/2023	Allergen preventive controls - Implement
Ken's Foods, Inc.	Food and Cosmetics	08/29/2023	Sanitation preventive controls - Implement
Kent L. Wellish, M.D.	Drugs	02/13/2023	FD-1572, protocol compliance
Origin Biologics, LLC	Biologics	02/10/2023	Deviations--evaluation, cause, corrective action
Origin Biologics, LLC	Biologics	02/10/2023	Procedures to meet core CTGP
Origin Biologics, LLC	Biologics	02/10/2023	Adequate control, proper conditions
Origin Biologics, LLC	Biologics	02/10/2023	Aseptic processing---cleaning, disinfecting
Origin Biologics, LLC	Biologics	02/10/2023	Calibrated per established schedules
Origin Biologics, LLC	Biologics	02/10/2023	Process validation procedures
Origin Biologics, LLC	Biologics	02/10/2023	Contamination, mix ups, improper release
Tomi Enterprises, LLC	Food and Cosmetics	04/13/2023	Develop FSVP