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Friday, January 17, 2025

FDA issued 11 citations in cities across Clark County in Q4 2023

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

There were three companies in cities associated with Clark 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 200% increase over the number of companies cited in the previous quarter.

Of the 11 citations issued, the most common citation was 'Your quality control operations did not include approving, and releasing from quarantine, all components before they were used'.

All 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.

Companies located within Clark County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Geneva Manufacturing, LLCFood and Cosmetics11/15/2023Specifications - component identity
Geneva Manufacturing, LLCFood and Cosmetics11/15/2023Specifications-component purity, strength, composition
Geneva Manufacturing, LLCFood and Cosmetics11/15/2023Specifications - contamination limits
Geneva Manufacturing, LLCFood and Cosmetics11/15/2023Specifications - identity, purity, strength, composition
Geneva Manufacturing, LLCFood and Cosmetics11/15/2023Document - material review, disposition
Geneva Manufacturing, LLCFood and Cosmetics11/15/2023Quality control operations - quarantine
Gramercy BakeryFood and Cosmetics10/13/2023Plant operations - Precautions
Gramercy BakeryFood and Cosmetics10/13/2023Storage and Distribution
Hard Eight Nutrition, LLCFood and Cosmetics10/04/2023Quality control operations - quarantine
Hard Eight Nutrition, LLCFood and Cosmetics10/04/2023Quality control operations - finished batch, specifications
Hard Eight Nutrition, LLCFood and Cosmetics10/04/2023Sanitation preventive controls - Appropriate (Adequate)

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