Atlas

Form 483

BioLife Plasma Services L.P. Form 483, 2011-11-22

FDA issued a Form 483 to BioLife Plasma Services L.P. on 2011-11-22 with 1 public-safe observation.

483· Form 483 issued1 observation

BioLife Plasma Services L.P. · Elkhart, United States · Issued November 22, 2011

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.

22 Nov 2011
21 CFR 606.100(b)

Written SOPs available for use by personnel

Cited by Myra K Casey

Inspected site

BPBioLife Plasma Services L.P.Elkhart, United States

Inspection team

MKMyra K Casey

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