West Indy News

There was one company in a city associated with Hendricks County that received FDA citations as a result of one inspection conducted in the county throughout 2023, 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 year.

The citations in the county include:

• Procedures were not designed to ensure compliance with the donor eligibility requirements.
• HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
• HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend.

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
BHC, LLC	Biologics	06/30/2023	Design of procedures to ensure compliance
BHC, LLC	Biologics	06/30/2023	Determination based on screening and testing
BHC, LLC	Biologics	06/30/2023	Labeled re: biohazard, risks, test results
BHC, LLC	Biologics	06/30/2023	Physician notification (limited use)
BHC, LLC	Biologics	06/30/2023	Procedures and release criteria
BHC, LLC	Biologics	06/30/2023	Clear and accurate label