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Wednesday, December 25, 2024

FDA: 2 companies in cities within Wilson County received 3 citations in Q4 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

There were two companies in a city associated with Wilson County that received FDA citations as a result of two 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 an increase over the number of companies cited in the previous quarter.

The citations in the county include:

  • Procedures for corrective and preventive action have not been established.
  • Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
  • There is no quality control unit.

Both 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 Wilson County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Fidelitone Order Fulfillment, LLCDrugs10/26/2023Lack of quality control unit
Max Mobility, LLCDevices12/07/2023Lack of or inadequate procedures
Max Mobility, LLCDevices12/07/2023Lack of or inadequate complaint procedures

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