Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county were 'Failure of standard operating procedures for compatibility testing to include procedures to expedite transfusions in life-threatening emergencies' and 'Failure to maintain general records'.
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 |
---|---|---|---|
Cone Health | Biologics | 02/27/2024 | Procedures to expedite transfusions in emergencies |
Cone Health | Biologics | 02/27/2024 | Required records |