FDA-Inspected Site

LEESAR, INC

5 FDA inspections are on record for LEESAR, INC in Fort Myers, United States.

483· Form 483 issued

Fort Myers, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-18.

At a glance

Inspections

5

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Jul 2025 – 18 Jul 2025Medical Devices & Rad Health483On file
29 Apr 2025 – 9 May 2025Human Drugs483View 483 →
18 Oct 2021 – 29 Oct 2021Human Drugs483View 483 →
3 Jul 2017 – 12 Jul 2017Human DrugsWLView 483 →
4 Aug 2014 – 8 Aug 2014Human Drugs483On file

Observations on record

Form 483 observations cited at this site, most recent first.

9 May 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Kayla V Sprague

9 May 2025
21 CFR 211.180(e)

Records reviewed annually

Cited by Kayla V Sprague

9 May 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Kayla V Sprague

9 May 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Kayla V Sprague

29 Oct 2021
21 CFR 211.110(a)

Written in-process control procedures

Cited by Jennifer Lalama, Kayla V Sprague

Investigators

FDA investigators tied to this site in the record.

Gisselle I Sensebe1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(vi)Cited across public-safe Form 483 observations1x
FDCA 503B(b)(2)(A)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind LEESAR, INC's 5 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat