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
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.
| 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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