Lee Today

There were four companies in cities associated with Lee 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 42.9% decrease from the number of companies cited in the previous year.

Of the nine citations issued, the most common citation was 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established'.

Most of the companies cited were involved in the Devices 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
EmCyte Corporation	Devices	11/15/2023	Documentation
EmCyte Corporation	Devices	11/15/2023	Lack of or inadequate complaint procedures
KSG Trade Company	Food and Cosmetics	03/02/2023	Develop FSVP
Pro Med Instruments, Inc.	Devices	02/15/2023	Whether reporter is an importer
Pro Med Instruments, Inc.	Devices	02/15/2023	Contamination control, Lack of or inadequate procedures
Pro Med Instruments, Inc.	Devices	02/15/2023	Lack of or inadequate complaint procedures
Pro Med Instruments, Inc.	Devices	02/15/2023	Service reports
Southwest Florida Fertility Center, P. A.	Biologics	03/08/2023	Testing, screening, donor eligibility procedures
Southwest Florida Fertility Center, P. A.	Biologics	03/08/2023	Risk factors, clinical evidence