Atlas

Form 483

Draeger, Inc. Form 483, 2009-07-09

FDA issued a Form 483 to Draeger, Inc. on 2009-07-09 with 1 public-safe observation.

483· Form 483 issued1 observation

Draeger, Inc. · Telford, United States · Issued July 9, 2009

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Jul 2009
21 CFR 820.198(a)(1)

Uniform and timely processing

Cited by James M Odonnell, Norman Wong

Inspected site

DIDraeger, Inc.Telford, United States

Inspection team

JMJames M Odonnell
NWNorman Wong

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)(1)Cited 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