FDA: 2 companies in cities within Ada County received 11 citations in Q1

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
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There were two companies in a city associated with Ada County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2024, 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.

Of the 11 citations issued, the most common citation was ‘Access to the storage area for labels and labeling materials is not limited to authorized personnel’.

Both companies cited were involved in the Drugs sector.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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 Ada County Cities and the citations they received in Q1
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
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


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