Atlas

Form 483

BPL Plasma, Inc. Form 483, 2010-05-06

FDA issued a Form 483 to BPL Plasma, Inc. on 2010-05-06 with 1 public-safe observation.

483· Form 483 issued1 observation

BPL Plasma, Inc. · College Station, United States · Issued May 6, 2010

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.

6 May 2010
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Jocelyn C Turner, Darla J Christopher

Inspected site

BPBPL Plasma, Inc.College Station, United States

Inspection team

JCJocelyn C Turner
DJDarla J Christopher

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

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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