Atlas

Form 483

Hans Gelderblom, M.D., Ph.D. Form 483, 2019-03-08

FDA issued a Form 483 to Hans Gelderblom, M.D., Ph.D. on 2019-03-08 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Hans Gelderblom, M.D., Ph.D. · Leiden, Netherlands · Issued March 8, 2019

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.

8 Mar 2019
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Richard W Berning

Inspected site

HGHans Gelderblom, M.D., Ph.D.Leiden, Netherlands

Inspection team

RWRichard W Berning

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.62(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