North Fairfax News

There were two companies in cities associated with Fairfax County that received FDA citations as a result of two inspections 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 100% 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 and screening of HCT/P donors.
• The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
• Documentation of the responsible person who made the donor-eligibility determination was not maintained.

Both companies cited were involved in either Biologics or Drugs sectors.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Granules Pharmaceuticals, Inc.	Drugs	12/15/2023	Procedures not in writing, fully followed
Granules Pharmaceuticals, Inc.	Drugs	12/15/2023	Rejected Material Area
Granules Pharmaceuticals, Inc.	Drugs	12/15/2023	Buildings not maintained in good state of repair
Granules Pharmaceuticals, Inc.	Drugs	12/15/2023	Equipment Design, Size and Location
Granules Pharmaceuticals, Inc.	Drugs	12/15/2023	Cleaning / Sanitizing / Maintenance
Washington Fertility Center	Biologics	11/02/2023	Testing, screening, donor eligibility procedures
Washington Fertility Center	Biologics	11/02/2023	Responsible person to determine, document
Washington Fertility Center	Biologics	11/02/2023	Documentation--determination, by whom, date
Washington Fertility Center	Biologics	11/02/2023	Risk factors, clinical evidence
Washington Fertility Center	Biologics	11/02/2023	Infection with communicable disease agents
Washington Fertility Center	Biologics	11/02/2023	Eligibility not required--warning labels