LeeSar, Inc.
Form 483 issued October 29, 2021 · Fort Myers, Florida
- Inspection
- Oct 18 – Oct 29, 2021
- Investigators
- Jennifer Lalama· Kayla V. Sprague
- Observations
- 5
- Pages
- 5
- FEI number
- 3010166880
In short: On October 29, 2021, FDA issued a Form 483 with 5 observations to LeeSar, Inc. in Fort Myers, Florida (FEI 3010166880) after an inspection that ran Oct 18 – Oct 29, 2021. The investigators were Jennifer Lalama and Kayla V. Sprague. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 02
Written procedures are not established that describe the tests to be conducted on appropriate samples of…
- 03
The master production and control records are deficient in that they do not include a statement…
- 04FDCA 503B(b)(2)(A)
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) 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 5 observations on this Form 483, mostly about production, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected LeeSar, Inc.?
Jennifer Lalama and Kayla V. Sprague are named on this Form 483, for the inspection of Oct 18 – Oct 29, 2021. Each investigator has a profile showing what they cite most.
When was LeeSar, Inc. inspected by FDA?
The inspection ran Oct 18 – Oct 29, 2021, and the Form 483 is dated October 29, 2021.
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.