Atlas

Form 483

Karl Storz Endoscopy America Inc Form 483, 2019-06-04

FDA issued a Form 483 to Karl Storz Endoscopy America Inc on 2019-06-04 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Karl Storz Endoscopy America Inc · Auburn, United States · Issued June 4, 2019

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.

4 Jun 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jeffrey J Thibodeau

4 Jun 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jeffrey J Thibodeau

4 Jun 2019
21 CFR 820.120(d)

Records, DHR {see also 820.184(e)}

Cited by Jeffrey J Thibodeau

4 Jun 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jeffrey J Thibodeau

4 Jun 2019
21 CFR 820.120(d)

Records, DHR {see also 820.184(e)}

Cited by Jeffrey J Thibodeau

Inspected site

KSKarl Storz Endoscopy America IncAuburn, United States

Inspection team

JJJeffrey J Thibodeau

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.120(d)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 6 observations

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