Pulaski Times

There was one company in a city associated with Pulaski 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 unchanged from the number of companies cited in the previous year.

The citations in the county include:

• Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
• Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.

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
SCA Pharmaceuticals, Inc.	Drugs	05/17/2023	Air Supply
SCA Pharmaceuticals, Inc.	Drugs	05/17/2023	Environmental Monitoring System
SCA Pharmaceuticals, Inc.	Drugs	05/17/2023	Equipment Design, Size and Location
SCA Pharmaceuticals, Inc.	Drugs	05/17/2023	Investigations of discrepancies, failures