There was one company in a city associated with Essex County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 50% decrease from the number of companies cited in the previous quarter.
The citations in the county were ‘Written standard operating procedures including all steps to be followed in the processing of blood and blood components for allogeneic transfusion, autologous transfusion and further manufacturing purposes were not always followed’ and ‘Records are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced’.
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 |
|---|---|---|---|
| Newark Beth Israel Medical Center – Blood Bank | Biologics | 10/13/2023 | Establish, maintain and follow manufacturing SOPs |
| Newark Beth Israel Medical Center – Blood Bank | Biologics | 10/13/2023 | Concurrent documentation |
