Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is an 85.7% decrease from the number of companies cited in the previous quarter.
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 |
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