Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- Input to and output from the computer and records or data are not checked for accuracy.
- The batch production and control records are deficient in that they do not include the identity of major equipment used.
- Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
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 |
|---|---|---|---|
| Corixa Corporation | Biologics | 02/09/2024 | input/output verification |
| Corixa Corporation | Biologics | 02/09/2024 | Identification of Equipment and Lines |
| Corixa Corporation | Biologics | 02/09/2024 | Biological product deviation report |
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