Atlas

Form 483

Edward W Sparrow Hospital Association Form 483, 2012-12-10

FDA issued a Form 483 to Edward W Sparrow Hospital Association on 2012-12-10 with 2 public-safe observations.

483· Form 483 issued2 observations

Edward W Sparrow Hospital Association · Lansing, United States · Issued December 10, 2012

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.

10 Dec 2012
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by L'Oreal F Walker

10 Dec 2012
21 CFR 606.100(c)

Thorough investigations

Cited by L'Oreal F Walker

Inspected site

EWEdward W Sparrow Hospital AssociationLansing, United States

Inspection team

LFL'Oreal F Walker

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)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