Atlas

Form 483

Octapharma Plasma, Inc. Form 483, 2015-08-10

FDA issued a Form 483 to Octapharma Plasma, Inc. on 2015-08-10 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Octapharma Plasma, Inc. · Fort Worth, United States · Issued August 10, 2015

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

10 Aug 2015
21 CFR 606.100(a)

SOP compliance

Cited by Amanda J White, Monique S Frazier, Samuel J Arsenault

Inspected site

OPOctapharma Plasma, Inc.Fort Worth, United States

Inspection team

AJAmanda J White
MSMonique S Frazier
SJSamuel J Arsenault

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(a)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