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 a 100% increase over the number of companies cited in the previous year.
The citations in the county were 'Failure to maintain facilities in a clean and orderly manner' and 'Records are not concurrently maintained with the performance of each significant step in the collection and processing of each unit of blood and blood components so that all steps can be clearly traced'.
Both companies cited should take voluntary actions to correct their 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.
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 |
|---|---|---|---|
| CSL Plasma, Inc. | Biologics | 07/12/2024 | Clean & orderly |
| Versiti Michigan, Inc. | Biologics | 09/26/2024 | Concurrent documentation |
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