There were two companies in cities associated with New Castle County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
No companies were cited in the previous quarter.
The citations in the county include:
- You did not provide an FSVP record electronically, or through another means to deliver the record promptly to FDA, after FDA requested the record in writing.
- An investigation was not conducted in accordance with the investigational plan.
- Investigational drug disposition records are not adequate with respect to quantity.
Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Hummayun Ismail, M.D. | Drugs | 08/01/2025 | FD-1572, protocol compliance |
| Hummayun Ismail, M.D. | Drugs | 08/01/2025 | Accountability records |
| Hummayun Ismail, M.D. | Drugs | 08/01/2025 | Case history records- inadequate or inadequate |
| JMT Inter, LLC | Food and Cosmetics | 09/23/2025 | Record – electronic |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
