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Thursday, November 21, 2024

How many companies in cities across Gwinnett County received FDA citations in Q3?

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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 was one company in a city associated with Gwinnett County that received FDA citations as a result of one inspection conducted in the county over the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

  • Procedures for corrective and preventive action have not been adequately established.
  • The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
  • A device history record has not been adequately maintained.

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 Gwinnett County Cities and the citations they received in Q3
Company NameArea of BusinessInspection DateIssue Cited
Technical Products, Inc.Devices07/25/2024Lack of or inadequate procedures
Technical Products, Inc.Devices07/25/2024DHR documentation of label release {see also 820.184}
Technical Products, Inc.Devices07/25/2024DHR - not or inadequately maintained

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