Atlas

Form 483

Johns Hopkins University Laboratory Form 483, 2019-06-14

FDA issued a Form 483 to Johns Hopkins University Laboratory on 2019-06-14 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Johns Hopkins University Laboratory · Baltimore, United States · Issued June 14, 2019

Overview

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

Inspectional observations

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

14 Jun 2019
21 CFR 58.107

Test article: handling

Cited by David L Chon, Anne E Johnson

14 Jun 2019
21 CFR 58.185(a)(9)

Final report: circumstances affecting data qual., integrity

Cited by David L Chon, Anne E Johnson

14 Jun 2019
21 CFR 58.33(e)

Study director: follow GLP regulations

Cited by David L Chon, Anne E Johnson

14 Jun 2019
21 CFR 58.81(b)

SOPs: required

Cited by David L Chon, Anne E Johnson

Inspected site

JHJohns Hopkins University LaboratoryBaltimore, United States

Inspection team

DLDavid L Chon
AEAnne E Johnson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 58.107Cited across public-safe Form 483 observations1x
21 CFR 58.185(a)(9)Cited across public-safe Form 483 observations1x
21 CFR 58.33(e)Cited across public-safe Form 483 observations1x
21 CFR 58.81(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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