Atlas

Form 483

Dartmouth Hitchcock Medical Center Form 483, 2014-07-23

FDA issued a Form 483 to Dartmouth Hitchcock Medical Center on 2014-07-23 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Dartmouth Hitchcock Medical Center · Lebanon, United States · Issued July 23, 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.

23 Jul 2014
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Alan R Condon

Inspected site

DHDartmouth Hitchcock Medical CenterLebanon, United States

Inspection team

ARAlan R Condon

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)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