Montgomery News

There was one company in a city associated with Montgomery County that received FDA citations as a result of one inspection conducted in the county over the fourth 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:

• Equipment used in the processing of blood and blood components is not standardized and calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
• Failure to notify consignees of the results of further testing for HIV within 45 calendar days after the donor tests reactive for evidence of HIV infection under the regulations.
• Failure to notify consignees of the results of further testing for HCV within 45 calendar days after the donor tests reactive for evidence of HCV infection under the regulations.

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
Department of Defense - Navy	Biologics	10/03/2024	Equipment observed, standardized, calibrated
Department of Defense - Navy	Biologics	10/03/2024	Notify Consignees [Collecting Establishment]
Department of Defense - Navy	Biologics	10/03/2024	Notify Consignees [Collecting Establishment]
Department of Defense - Navy	Biologics	10/03/2024	Physical Assessment Determination - Skin Examination