Atlas

Form 483

CSL Plasma, Inc. Form 483, 2017-02-09

FDA issued a Form 483 to CSL Plasma, Inc. on 2017-02-09 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

CSL Plasma, Inc. · Bloomington, United States · Issued February 9, 2017

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.

9 Feb 2017
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Melissa D Kalik

Inspected site

CPCSL Plasma, Inc.Bloomington, United States

Inspection team

MDMelissa D Kalik

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