North Palm Beach Today

There was one company in a city associated with Palm Beach County that received FDA citations as a result of one inspection conducted in the county in February, 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 month.

The citations in the county include:

• The quality control unit lacks authority to fully investigate errors that have occurred.
• The quality control unit lacks responsibility for approving or rejecting drug products processed under contract by another company.
• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

The company cited was involved in the Drugs sector.

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
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Authority lacking to review records, investigate errors
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Contract drug products--lack of responsibility
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Procedures not in writing, fully followed
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Aseptic Processing Area
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Scientifically sound laboratory controls
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Drug product sample
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Prepared for each batch, include complete information
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Identification of Person Performing Review of Lab Records
Horizon Pharmaceuticals, Inc.	Drugs	02/16/2024	Complaint Investigation/Follow-Up Findings