Columbia Standard

There was one company in a city associated with Kershaw County that received FDA citations as a result of one inspection conducted in the county over the second quarter of 2024, 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 quarter.

The citations in the county were 'Labeling was not sufficiently examined by a designated individual for accuracy including unique device identifier (UDI) or universal product code (UPC)' and 'Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR'.

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
Surgical Technology Laboratories, Inc.	Devices	05/10/2024	Labeling inspection - UDI
Surgical Technology Laboratories, Inc.	Devices	05/10/2024	Records, DHR {see also 820.184(e)}