North Fairfax News

There were six companies in cities associated with Fairfax County that received FDA citations as a result of six inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 14.3% decrease from the number of companies cited in the previous year.

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.

Most of the companies cited were involved in either Biologics or Food and Cosmetics sectors.

Of the companies cited, five should take voluntary actions to correct their managing operations (83.3%). Additionally, one company had to take regulatory and/or administrative actions (16.7%).

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
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Hygienic practices
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Ag. water - annual inspection
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Equipment installation, maintenance
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Non-food-contact surface maintenance and cleaning
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Pest contamination in buildings
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Sanitary food contact surfaces
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Environmental testing requirements
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Testing spent irrigation water
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Written environmental monitoring plan
Happy Sprout, Inc.	Food and Cosmetics	08/03/2023	Written sampling plan for spent irrigation water or sprouts
Imagine Milling Technologies, LLC	Devices	02/01/2023	Quality Audit/Reaudit - conducted
NL to US	Food and Cosmetics	05/02/2023	Develop FSVP
Virginia Center for Reproductive Medicine	Biologics	09/20/2023	Testing, screening, donor eligibility procedures
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