Atlas

Form 483

Octapharma Plasma, Inc. Form 483, 2018-10-19

FDA issued a Form 483 to Octapharma Plasma, Inc. on 2018-10-19 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Octapharma Plasma, Inc. · Redford, United States · Issued October 19, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

19 Oct 2018
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Susan M North

19 Oct 2018
21 CFR 606.40

Clean & orderly

Cited by Susan M North

Inspected site

OPOctapharma Plasma, Inc.Redford, United States

Inspection team

SMSusan M North

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.40Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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