Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
- 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.
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 |
|---|---|---|---|
| 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 |
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