Duval Times

There was one company in a city associated with Duval County that received FDA citations as a result of one inspection conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• You did not establish and maintain procedures for testing of HCT/P donors.
• HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
• The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.

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
North Florida Reproductive Biology Laboratory	Biologics	04/12/2024	Testing, screening, donor eligibility procedures
North Florida Reproductive Biology Laboratory	Biologics	04/12/2024	Determination based on screening and testing
North Florida Reproductive Biology Laboratory	Biologics	04/12/2024	Statement re: certified testing lab
North Florida Reproductive Biology Laboratory	Biologics	04/12/2024	Listing and interpretation of CD tests performed
North Florida Reproductive Biology Laboratory	Biologics	04/12/2024	Labeled re: biohazard, risks, test results