There were four companies in cities associated with Fairfield County that received FDA citations as a result of four inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 33.3% decrease from the number of companies cited in the previous year.
The citations in the county include:
- Written MDR procedures have not been maintained.
- A device master record has not been adequately maintained.
- Informed consent was not properly documented in that the written informed consent used in the study was not approved by the IRB.
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.
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 |
|---|---|---|---|
| Divvies, LLC | Food and Cosmetics | 01/26/2023 | Equipment and utensils – Design and maintenance |
| Glenn Gandelman, M.D. | Drugs | 03/10/2023 | Consent form not approved/signed/dated |
| Glenn Gandelman, M.D. | Drugs | 03/10/2023 | Informed consent |
| Purdue Pharma L. P. | Drugs | 10/05/2023 | Failure to develop written procedures |
| Purdue Pharma L. P. | Drugs | 10/05/2023 | Late submission of 15-day report |
| Purdue Pharma L. P. | Drugs | 10/05/2023 | Failure to report non-alert ADEs |
| Purdue Pharma L. P. | Drugs | 10/05/2023 | Late submission of an ICSR |
| Remote Technologies, Inc. | Devices | 11/08/2023 | Lack of Written MDR Procedures |
| Remote Technologies, Inc. | Devices | 11/08/2023 | DMR – not or inadequately maintained |
