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Monday, December 23, 2024

FDA: 1 company in cities within Ellis County received 2 citations in Q4 2023

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

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

This is an increase over the number of companies cited in the previous quarter.

The citations in the county were 'Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established' and 'Procedures for finished device acceptance have not been adequately established'.

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.

Companies located within Ellis County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Raye's, Inc.Devices11/02/2023Purchasing controls, Lack of or inadequate procedures
Raye's, Inc.Devices11/02/2023Lack of or inadequate final acceptance procedures

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