SW Connecticut News

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