FDA Intel

LeeSar, Inc.

Form 483 issued July 12, 2017 · Fort Myers, Florida

Inspection
Jul 3 – Jul 12, 2017
Investigators
Ian F. Deveau· Jennifer Lalama· June P. Page
Observations
5
Pages
5
FEI number
3010166880

In short: On July 12, 2017, FDA issued a Form 483 with 5 observations to LeeSar, Inc. in Fort Myers, Florida (FEI 3010166880) after an inspection that ran Jul 3 – Jul 12, 2017. The investigators were Ian F. Deveau, Jennifer Lalama, June P. Page and Justine C. Tomasso. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 3 of 5 observations.

Facilities & equipment2
Production1
Quality system1
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.42(c)(10)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…

  2. 02
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be…

  3. 03
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…

  4. 04
    21 CFR 211.42(c)(10)(vi)

    Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Ian F. Deveau

1 document · 2017

Cites 211.42(c)(10)(v) (design and construction features) more than any other section. Most of their documents are for sites in Florida.

The firm

LeeSar, Inc. history

All 7 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42(c)(10)(v)

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 facilities & equipment, production and quality system. 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.?

Ian F. Deveau, Jennifer Lalama, June P. Page and Justine C. Tomasso are named on this Form 483, for the inspection of Jul 3 – Jul 12, 2017. Each investigator has a profile showing what they cite most.

When was LeeSar, Inc. inspected by FDA?

The inspection ran Jul 3 – Jul 12, 2017, and the Form 483 is dated July 12, 2017.

How do I get the full Form 483 for LeeSar, Inc.?

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