Leesar Inc.
FDA 503B outsourcing facility
Fort Myers, Florida
Key Takeaways
- FDA-registered 503B outsourcing facility since 2014
- Sterile compounding from bulk substances: No
- Last FDA inspection: May 9, 2025
- FDA action: Untitled Letter Issued 11/21/2025
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- April 30, 2014
- Most recent registration
- November 26, 2025
- Compounds sterile drugs from bulk substances
- No
- Last FDA inspection
- May 9, 2025
The FDA last inspected Leesar Inc. on May 9, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. FDA action on record: Untitled Letter Issued 11/21/2025.
What this facility compounds
Leesar Inc. reports compounding 12 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Oxytocin.
- Amiodarone Hydrochloride
- Azithromycin Anhydrous
- Dexmedetomidine Hydrochloride
- Diltiazem Hydrochloride
- Heparin Sodium
- Hydromorphone Hydrochloride
- Lidocaine Hydrochloride Anhydrous; Lidocaine Hydrochloride
- Norepinephrine Bitartrate
- Oxytocin
- Phenylephrine Hydrochloride
- Succinylcholine Chloride
- Vancomycin Hydrochloride
Contact
FDA-registered contact: Maria Gautier, 1-239-939-8925. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Leesar Inc. with the Florida Board of Pharmacy.
503B facilities in Florida
Florida has 16 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Florida.
Frequently asked questions
Is Leesar Inc. registered with the FDA?
Yes. Leesar Inc. is a registered 503B outsourcing facility, first registered with the FDA on April 30, 2014 and most recently registered on November 26, 2025.
Has Leesar Inc. been inspected by the FDA?
The FDA last inspected Leesar Inc. on May 9, 2025. A Form FDA 483 was issued. FDA action on record: Untitled Letter Issued 11/21/2025.
Has Leesar Inc. had any FDA drug recalls?
No FDA drug recalls are matched to Leesar Inc. in the openFDA enforcement database.
What does Leesar Inc. compound?
Leesar Inc. reports compounding 12 active ingredients to the FDA, including Oxytocin.
Where is Leesar Inc. located?
Leesar Inc. is located in Fort Myers, Florida.
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Leesar Inc.. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.