LeeSar, Inc.
FDA inspection history across 2 sites, 2014 to 2025
- 4
- Form 483s
- 1
- Untitled letter
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Untitled letter
- Form 483
- Warning letter
- Close-out
2014: one Form 483; 2017: one Form 483; 2020: one close-out letter; 2021: one Form 483; 2022: one warning letter; 2025: one untitled letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Fort Myers, Florida.
- 2014The longest 483 on file: 6 observations over 2 pages at Fort Myers, Florida.
- 2017One Form 483, at Fort Myers, Florida.
- 2020–22One close-out letter, one Form 483 and one warning letter, at Fort Myers, Florida and Florida.
- 2025One untitled letter and one Form 483, at Fort Myers, Florida.
Cited most
Across all LeeSar observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete LeeSar file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Fort Myers, Florida
Four Form 483s, one untitled letter and one close-out letter · 2014 to 2025 · 20 observations
Latest: Untitled letter, Nov 21, 2025 →Florida
One warning letter · 2022
Latest: Warning letter, Jun 17, 2022 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-11-21 | Untitled letter Untitled letter | Fort Myers, Florida | — | $99 |
| 2025-05-09 | 483 Form 483 | Fort Myers, Florida | 4 | $99 |
| 2022-06-17 | Warning letter Warning letter | Florida | — | $99 |
| 2021-10-29 | 483 Form 483 | Fort Myers, Florida | 5 | $99 |
| 2020-02-18 | Close-out Close-out letter | Fort Myers, Florida | — | $99 |
| 2017-07-12 | 483 Form 483 | Fort Myers, Florida | 5 | $99 |
| 2014-08-08 | 483 Form 483 | Fort Myers, Florida | 6 | $99 |
Investigators on these documents
Jennifer Lalama (2)Justine C. Tomasso (2)Kayla V. Sprague (2)Ian F. Deveau (1)June P. Page (1)
FEI number 3010166880 · most recent document Nov 21, 2025
About LeeSar, Inc.
How many FDA Form 483s has LeeSar, Inc. received?
FDA Intel has 4 Form 483s on file for LeeSar, Inc.; the most recent is dated May 9, 2025.
When was LeeSar, Inc. last inspected by FDA?
The most recent FDA inspection document on file for LeeSar, Inc. is a Form 483 dated May 9, 2025, for the site in Fort Myers, Florida.
What did FDA cite at LeeSar, Inc.?
The regulations cited most in the observations on file for LeeSar, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.
Has LeeSar, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for LeeSar, Inc.; the most recent is dated Jun 17, 2022.
Has LeeSar, Inc. received an FDA untitled letter?
Yes. FDA Intel has 1 FDA untitled letter on file for LeeSar, Inc.; the most recent is dated Nov 21, 2025. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.