Lee Memorial Health System, Fort Myers, FL – FDA Inspections

Inspection records and compliance data for Lee Memorial Health System in Fort Myers, Florida. 7 FDA inspections on record, last inspected February 13, 2026.

Company Profile

This profile covers Lee Memorial Health System based in Fort Myers, Florida, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 0
NAI: 6
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected February 23, 2010. Last inspected February 13, 2026.

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
February 13, 2026	Not classified	Biologics	1304248
November 22, 2021	NAI	Biologics · Vaccines and Allergenic Products	1157762
February 5, 2018	NAI	Biologics · Blood and Blood Products	1045474
December 1, 2015	NAI	Biologics · Blood and Blood Products	950928
February 24, 2014	NAI	Biologics · Blood and Blood Products	867164
March 9, 2012	NAI	Biologics · Blood and Blood Products	771591
February 23, 2010	NAI	Biologics · Blood and Blood Products	649965

FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Regenerative Biologics Inc

OneBlood, Inc.

Enfisa Biologics LLC

South Florida Institute for Reproductive Medicine/IVFMD

ORMC Hospital Laboratory

Lions Eye Institute for Transplant & Research, Inc.

Joshua M. Hare, MD

Bijal D. Shah, M.D.

Suncoast Communities Blood Bank Inc

H Lee Moffitt Cancer Center & Research Institute Hospital Inc