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 unchanged from the number of companies cited in the previous quarter.
The citations in the county were 'Biological product deviations were not reported within the 45 calendar day timeframe' and 'Written standard operating procedures including all steps to be followed in the collection, processing, compatibility testing, storage and distribution of blood and blood components for allogeneic transfusion were not always followed'.
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 |
|---|---|---|---|
| Ochsner Health System Blood Bank | Biologics | 07/05/2024 | When to report |
| Ochsner Health System Blood Bank | Biologics | 07/05/2024 | Establish, maintain and follow manufacturing SOPs |
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