How many companies in cities across Ada County received FDA citations in 2024?

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) - Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) - Official website
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There were four companies in cities associated with Ada County that received FDA citations as a result of four inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% increase over the number of companies cited in the previous year.

Of the 20 citations issued, the most common citations include:

  • Access to the storage area for labels and labeling materials is not limited to authorized personnel.
  • The IRB registration does not state the approximate number of active protocols involving FDA-regulated products reviewed.
  • The IRB did not revise its registration information with respect to changes in within 90 days of the change.

Most of the companies cited were involved in the Drugs sector.

Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).

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.

According to its website, 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.

Companies Located Within Ada County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
Episciences, Inc. Drugs 01/29/2024 Cleaning SOPs/instructions
Episciences, Inc. Drugs 01/29/2024 Components withheld from use pending release
Episciences, Inc. Drugs 01/29/2024 Distinctive ID or code not recorded in batch record
Episciences, Inc. Drugs 01/29/2024 Label storage access limited to authorized personnel
Episciences, Inc. Drugs 01/29/2024 Lack of written stability program
Global CPG, LLC Food and Cosmetics 04/16/2024 Develop FSVP
Global CPG, LLC Food and Cosmetics 04/16/2024 Approved supplier procedures – importer established
Global CPG, LLC Food and Cosmetics 04/16/2024 Supplier verification – establish written procedures
Omega Technician Labs, LLC Drugs 01/22/2024 Procedures not in writing, fully followed
Omega Technician Labs, LLC Drugs 01/22/2024 Cleaning/maintenance records not kept
Omega Technician Labs, LLC Drugs 01/22/2024 Identity Testing of Each Component
Omega Technician Labs, LLC Drugs 01/22/2024 Absence of Written Procedures
Omega Technician Labs, LLC Drugs 01/22/2024 Procedures for non-sterile drug products
Omega Technician Labs, LLC Drugs 01/22/2024 Label storage access limited to authorized personnel
Saint Alphonsus Institutional Review Board Devices 09/18/2024 Number of active protocols
Saint Alphonsus Institutional Review Board Devices 09/18/2024 Changes in contact or chairperson information
Saint Alphonsus Institutional Review Board Devices 09/18/2024 Initial and continuing reviews
Saint Alphonsus Institutional Review Board Drugs 09/18/2024 Number of active protocols
Saint Alphonsus Institutional Review Board Drugs 09/18/2024 Changes in contact or chairperson information
Saint Alphonsus Institutional Review Board Drugs 09/18/2024 Initial and continuing reviews


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