Atlas

Form 483

BPL Plasma, Inc. Form 483, 2018-11-13

FDA issued a Form 483 to BPL Plasma, Inc. on 2018-11-13 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

BPL Plasma, Inc. · Jacksonville, United States · Issued November 13, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

13 Nov 2018
21 CFR 606.171

Biological product deviation report

Cited by Barbara T Carmichael, Valerie J Grecek-Trinh, Julie D Bringger

13 Nov 2018
21 CFR 606.20(b)

Qualifications of responsible personnel

Cited by Barbara T Carmichael, Valerie J Grecek-Trinh, Julie D Bringger

13 Nov 2018
21 CFR 630.10(g)(1)

Proof Of Identity

Cited by Barbara T Carmichael, Valerie J Grecek-Trinh, Julie D Bringger

Inspected site

BPBPL Plasma, Inc.Jacksonville, United States

Inspection team

BTBarbara T Carmichael
VJValerie J Grecek-Trinh
JDJulie D Bringger

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.171Cited across public-safe Form 483 observations1x
21 CFR 606.20(b)Cited across public-safe Form 483 observations1x
21 CFR 630.10(g)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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