503B Docket

Leesar Inc. 503B outsourcing facility · Fort Myers, FL

This is a record of what FDA published, not a rating. Last FDA inspection and Form 483 status below are as published in FDA's registered outsourcing facilities table (as of Sep 30, 2026).

FDA registration record

Listed by FDA asLeesar Inc., Fort Myers, FL
City / stateFort Myers, FL
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)1-239-939-8925
Initial registration date4/30/2014
Most recent registration date11/26/2025
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)9/28/2026
Form 483 issued at last inspection?Yes
Recall conducted? (FDA table)No
Action based on last inspectionOpen
“Open” means FDA has not determined whether further action will be taken (per FDA's table notes).
Intends to compound sterile drugs from bulk substancesNo
Self-reported by the facility at registration; FDA notes this information has not been verified by FDA.
Prior compounding inspection history flagYes
FDA footnotes this facility as the subject of at least one previous compounding inspection that resulted in a Form 483, warning letter or other action.

Source: FDA Registered Outsourcing Facilities

Published FDA records

3Form 483 records
1Warning letters
0Recall events (openFDA)
0Uncertain-match items

Counts include only items from FDA's table or exact name + city + state matches. They are counts of published records, not a score. Uncertain matches are shown below but not counted.

State board of pharmacy license lookup

Florida Department of Health License Verification (Board of Pharmacy) (license lookup)

Search the state board's lookup for this facility's license status and any disciplinary actions. We link to the state-level tool only and do not list license numbers. FDA's table does not include state board actions. Facilities that ship across state lines may also hold non-resident licenses in your state, so check your own state's board too.

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Timeline of FDA actions

Newest first. Sources: FDA's registration table, FDA's compounding actions page (2019 onward on the live page), and openFDA drug enforcement records. Items marked Uncertain match may relate to a different site or entity and are not counted. How matching works.

  1. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    No document link published · FDA registered outsourcing facilities table
  2. Form FDA 483 FDA table
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published · FDA registered outsourcing facilities table
  3. Untitled letter Matched
    Untitled Letter issued 11/21/2025
    Listed on FDA page under: LeeSar, Inc., Fort Myers, FL - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  4. Form FDA 483 Matched
    483 Issued 05/09/2025 (PDF - 854KB)
    Listed on FDA page under: LeeSar, Inc., Fort Myers, FL - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  5. Untitled letter Matched
    Untitled Letter Issued 06/17/2022 (PDF - 7.62 MB)
    Listed on FDA page under: LeeSar, Inc., Fort Myers, FL - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  6. Form FDA 483 Matched
    483 Issued 10/29/2021 (PDF - 976KB)
    Listed on FDA page under: LeeSar, Inc., Fort Myers, FL - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  7. Warning letter Matched
    Warning Letter (02/18/2020)
    Listed on FDA page under: LeeSar, Inc., Fort Myers, FL - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions