LeeSar, Inc.
Form 483 issued May 9, 2025 · Fort Myers, Florida
- Inspection
- Apr 29 – May 9, 2025
- Investigator
- Kayla V. Sprague
- Observations
- 4
- Pages
- 4
- FEI number
- 3010166880
In short: On May 9, 2025, FDA issued a Form 483 with 4 observations to LeeSar, Inc. in Fort Myers, Florida (FEI 3010166880) after an inspection that ran Apr 29 – May 9, 2025. The investigator was Kayla V. Sprague. Most observations concern quality system and production.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmLeeSar, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LeeSar, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected LeeSar, Inc.?
Kayla V. Sprague is named on this Form 483, for the inspection of Apr 29 – May 9, 2025. Each investigator has a profile showing what they cite most.
When was LeeSar, Inc. inspected by FDA?
The inspection ran Apr 29 – May 9, 2025, and the Form 483 is dated May 9, 2025.
How do I get the full Form 483 for LeeSar, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.