South Tidewater News

There were three companies in the City of Norfolk that received FDA citations as a result of three inspections conducted in the city throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 200% increase over the number of companies cited in the previous year.

The citations in the city include:

• Procedures for finished device acceptance have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
• Failure to store platelets immediately after resuspension at 20 to 24 degrees Celsius with continuous gentle agitation.

Most of the companies cited were involved in the Biologics sector.

All of the companies cited should take voluntary actions to correct their 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
Lions Medical Eye Bank & Research Center of Eastern VA	Biologics	02/16/2023	Deviations--Investigation, documenting, trending
Lions Medical Eye Bank & Research Center of Eastern VA	Biologics	02/16/2023	Procedures to meet core CTGP
Lions Medical Eye Bank & Research Center of Eastern VA	Biologics	02/16/2023	Procedures inadequate
Lions Medical Eye Bank & Research Center of Eastern VA	Biologics	02/16/2023	Verification/validation
The American National Red Cross	Biologics	07/10/2023	Storage temps./agitation
Zimmer Biomet	Devices	08/18/2023	Lack of or inadequate final acceptance procedures
Zimmer Biomet	Devices	08/18/2023	Lack of or inadequate complaint procedures