Lee Today

There were 16 companies in cities associated with Lee County, Florida, that received 16 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 15.8% decrease from the number of companies inspected in the previous year, when 19 companies were inspected through 19 inspections.

Most of the companies inspected were involved in the Biologics sector. The second most common type of company inspected in the time period worked in the Food/Cosmetics sector.

There were 12 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (75%). Four should take voluntary action to correct the organization's management operations (25%).

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	Result
AVT Natural Products Limited	Food/Cosmetics	10/24/2023	No Action Indicated (NAI)
DT Water, LLC	Food/Cosmetics	01/20/2023	No Action Indicated (NAI)
EmCyte Corporation	Devices	11/15/2023	Voluntary Action Indicated (VAI)
Jimmy's Java	Food/Cosmetics	10/31/2023	No Action Indicated (NAI)
KSG Trade Company	Food/Cosmetics	03/02/2023	Voluntary Action Indicated (VAI)
Lee Memorial Health System - Donor Center	Biologics	07/31/2023	No Action Indicated (NAI)
Natural Health Partners, LLC	Food/Cosmetics	10/17/2023	No Action Indicated (NAI)
Octapharma Plasma, Inc.	Biologics	08/02/2023	No Action Indicated (NAI)
OneBlood, Inc.	Biologics	04/21/2023	No Action Indicated (NAI)
OneBlood, Inc.	Biologics	04/20/2023	No Action Indicated (NAI)
OneBlood, Inc.	Biologics	04/20/2023	No Action Indicated (NAI)
Plasma, Inc., BPC	Biologics	08/04/2023	No Action Indicated (NAI)
Pro Med Instruments, Inc.	Devices	02/15/2023	Voluntary Action Indicated (VAI)
Skeletal Dynamics Strategic Manufacturing	Devices	11/30/2023	No Action Indicated (NAI)
Southwest Florida Fertility Center, P. A.	Biologics	03/08/2023	Voluntary Action Indicated (VAI)
The Fine Cheese Company, LLC	Food/Cosmetics	06/30/2023	No Action Indicated (NAI)