Form 483

Abington Memorial Hospital,IRC Form 483, 2019-02-15

FDA issued a Form 483 to Abington Memorial Hospital,IRC on 2019-02-15 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Abington Memorial Hospital,IRC · Philadelphia, United States · Issued February 15, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

15 Feb 2019
21 CFR 56.108(c)

Members present for review

Cited by Kelly N Kerr

15 Feb 2019
21 CFR 56.110(c)

Method to keep members advised

Cited by Kelly N Kerr

15 Feb 2019
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Kelly N Kerr

Inspected site

AMAbington Memorial Hospital,IRCPhiladelphia, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.108(c)Cited across public-safe Form 483 observations1x
21 CFR 56.110(c)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 3 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