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Form 483

Pascal M. Jabbour, MD Form 483, 2017-12-19

FDA issued a Form 483 to Pascal M. Jabbour, MD on 2017-12-19 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Pascal M. Jabbour, MD · Philadelphia, United States · Issued December 19, 2017

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.

19 Dec 2017
21 CFR 50.27(a)

Consent form not approved/signed/dated

Cited by Marcelo O Mangalindan

19 Dec 2017
21 CFR 812.100

Investigator non-compliance with agreement/plan/regulations

Cited by Marcelo O Mangalindan

Inspected site

PMPascal M. Jabbour, MDPhiladelphia, United States

Inspection team

MOMarcelo O Mangalindan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.27(a)Cited across public-safe Form 483 observations1x
21 CFR 812.100Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

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