There was one company in a city associated with Suffolk County that received FDA citations as a result of one inspection conducted in the county in November 2024, 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:
- Written procedures have not been developed for the surveillance of post marketing adverse drug experiences.
- Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including information from commercial marketing experience.
- Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
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.
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 |
|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Drugs | 11/07/2024 | Failure to develop written procedures |
| Alexion Pharmaceuticals, Inc. | Drugs | 11/07/2024 | Failure to review ADE information |
| Alexion Pharmaceuticals, Inc. | Drugs | 11/07/2024 | Late submission of 15-day report |
| Alexion Pharmaceuticals, Inc. | Drugs | 11/07/2024 | Late submission of an ICSR |


