Atlas

Form 483

Sever Pharma Solutions AB Form 483, 2014-03-27

FDA issued a Form 483 to Sever Pharma Solutions AB on 2014-03-27 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Sever Pharma Solutions AB · Malmo, Sweden · Issued March 27, 2014

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.

27 Mar 2014
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Meisha R Sampson, Meisha R Waters

Inspected site

SPSever Pharma Solutions ABMalmo, Sweden

Inspection team

MRMeisha R Sampson
MRMeisha R Waters

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.103Cited 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