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North Birmingham Times

Wednesday, November 20, 2024

How many companies in cities across Cullman County received FDA citations in 2023?

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

There were two companies in cities associated with Cullman County that received FDA citations as a result of two inspections conducted in the county throughout 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 year.

The citations in the county include:

  • The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
  • Procedures for finished device acceptance have not been adequately established.
  • Procedures for rework of nonconforming product have not been adequately established.

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 Cullman County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Orchid Orthopedic Solutions Alabama, LLCDevices06/15/2023Lack of or inadequate organizational structure
Orchid Orthopedic Solutions Alabama, LLCDevices06/15/2023Lack of or inadequate final acceptance procedures
Orchid Orthopedic Solutions Alabama, LLCDevices06/15/2023Product rework procedures, Lack of or inadequate procedures
Richard HunterVeterinary06/30/2023Individual identity of animal(s)
Richard HunterVeterinary06/30/2023Record keeping

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