Atlas

Form 483

Olympus Winter & IBE Gmbh Form 483, 2014-12-04

FDA issued a Form 483 to Olympus Winter & IBE Gmbh on 2014-12-04 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Olympus Winter & IBE Gmbh · Hamburg, Germany · Issued December 4, 2014

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 Dec 2014
21 CFR 820.86

Acceptance status

Cited by Dennis R Hock

Inspected site

OWOlympus Winter & IBE GmbhHamburg, Germany

Inspection team

DRDennis R Hock

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.86Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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