Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
This is a 50% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Written standard operating procedures including all steps to be followed in the storage of blood and blood components for allogeneic transfusion were not always established, maintained and followed.
- Records are not concurrently maintained with the performance of each significant step in the distribution of each unit of blood and blood components so that all steps can be clearly traced.
- Failure to maintain general records.
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.
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 |
---|---|---|---|
Mount Sinai Hospital Blood Bank | Biologics | 07/02/2024 | Establish, maintain and follow manufacturing SOPs |
Mount Sinai Hospital Blood Bank | Biologics | 07/02/2024 | Concurrent documentation |
Mount Sinai Hospital Blood Bank | Biologics | 07/02/2024 | Required records |
NYU Langone Hospitals | Biologics | 09/26/2024 | Establish, maintain and follow manufacturing SOPs |
NYU Langone Hospitals | Biologics | 09/26/2024 | Establishment of spec., standards, and test procedures |