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Form 483

Aesculap Inc Form 483, 2016-09-14

FDA issued a Form 483 to Aesculap Inc on 2016-09-14 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Aesculap Inc · Hazelwood, United States · Issued September 14, 2016

Overview

  • 6 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.

14 Sep 2016
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Eric M Padgett

14 Sep 2016
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Eric M Padgett

14 Sep 2016
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Eric M Padgett

14 Sep 2016
21 CFR 820.100(b)

Documentation

Cited by Eric M Padgett

14 Sep 2016
21 CFR 820.100(b)

Documentation

Cited by Eric M Padgett

Inspected site

AIAesculap IncHazelwood, United States

Inspection team

EMEric M Padgett

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 820.100(b)Cited across public-safe Form 483 observations3x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF, 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