Form 483

Edward W Sparrow Hospital Association Form 483, 2019-03-18

FDA issued a Form 483 to Edward W Sparrow Hospital Association on 2019-03-18 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Edward W Sparrow Hospital Association · Lansing, United States · Issued March 18, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

18 Mar 2019
21 CFR 610.47(b)(3)

Notify Transfusion Recipients or MD of Record [Consignee]

Cited by Erma Zaimova

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 610.47(b)(3)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

The source PDF and 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