SLC Times

There was one company in a city associated with Salt Lake County that received FDA citations as a result of one inspection 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 75% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
• Procedures describing the warehousing of drug products are not established.
• Written distribution procedures are not established.

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
CellSure, L3C	Biologics	12/08/2023	Approve or reject procedures or specs
CellSure, L3C	Biologics	12/08/2023	Written warehousing procedures established/followed
CellSure, L3C	Biologics	12/08/2023	Written distribution procedure
CellSure, L3C	Biologics	12/08/2023	Lack of written stability program
CellSure, L3C	Biologics	12/08/2023	Risk factors, clinical evidence
CellSure, L3C	Biologics	12/08/2023	Eligibility not required--warning labels