LeeSar, Inc.
Form 483 issued August 8, 2014 · Fort Myers, Florida
- Inspection
- Aug 4 – Aug 8, 2014
- Investigator
- Justine C. Tomasso
- Observations
- 6
- Pages
- 2
- FEI number
- 3010166880
In short: On August 8, 2014, FDA issued a Form 483 with 6 observations to LeeSar, Inc. in Fort Myers, Florida (FEI 3010166880) after an inspection that ran Aug 4 – Aug 8, 2014. The investigator was Justine C. Tomasso. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 3 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Justine C. Tomasso
5 documents · 2012–2025
Cites 211.42 (design and construction features) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LeeSar, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected LeeSar, Inc.?
Justine C. Tomasso is named on this Form 483, for the inspection of Aug 4 – Aug 8, 2014. Each investigator has a profile showing what they cite most.
When was LeeSar, Inc. inspected by FDA?
The inspection ran Aug 4 – Aug 8, 2014, and the Form 483 is dated August 8, 2014.
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.