There were five companies in cities associated with Montgomery County that received FDA citations as a result of five inspections conducted in the county throughout 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 year.
Of the 16 citations issued, the most common citation was ‘There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed’.
Most of the companies cited were involved in the Drugs sector.
All of the companies cited should take voluntary actions to correct their 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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | Drugs | 05/31/2024 | Procedures not in writing, fully followed |
| AstraZeneca Pharmaceuticals LP | Drugs | 05/31/2024 | Investigations of discrepancies, failures |
| AstraZeneca Pharmaceuticals LP | Drugs | 05/31/2024 | Complete Test Data |
| AstraZeneca Pharmaceuticals LP | Drugs | 05/31/2024 | Complaint Handling Procedure |
| Department of Defense – Navy | Biologics | 10/03/2024 | Equipment observed, standardized, calibrated |
| Department of Defense – Navy | Biologics | 10/03/2024 | Notify Consignees [Collecting Establishment] |
| Department of Defense – Navy | Biologics | 10/03/2024 | Notify Consignees [Collecting Establishment] |
| Department of Defense – Navy | Biologics | 10/03/2024 | Physical Assessment Determination – Skin Examination |
| Righteye, LLC | Devices | 03/08/2024 | Design Validation – Risk analysis not performed/inadequate |
| SUCO, Inc. | Drugs | 02/25/2024 | Equipment Design, Size and Location |
| SUCO, Inc. | Drugs | 02/25/2024 | Absence of Written Procedures |
| SUCO, Inc. | Drugs | 02/25/2024 | Representative Number of Batches for Annual Review |
| SUCO, Inc. | Drugs | 02/25/2024 | Batch production and Batch Control Record Requirements |
| United Therapeutics Corporation | Drugs | 05/02/2024 | Reports of Analysis (Components) |
| United Therapeutics Corporation | Drugs | 05/02/2024 | Procedures for sterile drug products |
| United Therapeutics Corporation | Drugs | 05/02/2024 | Investigations of discrepancies, failures |
