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 month.
The citations in the county were 'Schedules for the adjustment, cleaning, and other maintenance of equipment have not been adequately established' and 'Software used as part of production has not been adequately validated for its intended use according to an established protocol'.
The company cited should take a voluntary action to correct its 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Nalge Nunc International Corporation | Devices | 01/05/2024 | Maintenance schedule, Lack of or inadequate schedule |
| Nalge Nunc International Corporation | Devices | 01/05/2024 | Software validation for automated processes |
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