Atlas

Form 483

OD-OS GmbH Form 483, 2017-11-30

FDA issued a Form 483 to OD-OS GmbH on 2017-11-30 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

OD-OS GmbH · Teltow, Germany · Issued November 30, 2017

Overview

  • 3 public-safe observations are 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.

30 Nov 2017
21 CFR 820.30(f)

Design verification - documentation

Cited by Stanley B Eugene

30 Nov 2017
21 CFR 820.30(f)

Design verification - documentation

Cited by Stanley B Eugene

30 Nov 2017
21 CFR 820.30(f)

Design verification - documentation

Cited by Stanley B Eugene

Inspected site

OGOD-OS GmbHTeltow, Germany

Inspection team

SBStanley B Eugene

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(f)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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