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.
| 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 |



