Columbia Standard

There was one company in a city associated with Lexington County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

• Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
• Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the sterilization process.
• Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.

The company cited had to take regulatory and/or administrative actions.

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
Nephron School, Inc.	Drugs	02/09/2024	Procedures for sterile drug products
Nephron School, Inc.	Drugs	02/09/2024	Validation lacking for sterile drug products
Nephron School, Inc.	Drugs	02/09/2024	Establishment of calibration procedures