Atlas

Form 483

Lee Memorial Health System Form 483, 2018-02-09

FDA issued a Form 483 to Lee Memorial Health System on 2018-02-09 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Lee Memorial Health System · Fort Myers, United States · Issued February 9, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Feb 2018
21 CFR 630.10(g)(2)(ii)

Donor's Acknowledgment - Exculpatory language

Cited by Lura D Baquero

9 Feb 2018
21 CFR 630.40(a)

Notification

Cited by Lura D Baquero

Inspected site

LMLee Memorial Health SystemFort Myers, United States

Inspection team

LDLura D Baquero

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 630.10(g)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 630.40(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere