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Form 483

CSL Plasma, Inc Form 483, 2020-02-12

FDA issued a Form 483 to CSL Plasma, Inc on 2020-02-12 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

CSL Plasma, Inc · Minneapolis, United States · Issued February 12, 2020

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.

12 Feb 2020
21 CFR 606.171

Biological product deviation report

Cited by Melissa D Kalik

12 Feb 2020
21 CFR 630.10(c)

Donor Eligibility on day of donation

Cited by Melissa D Kalik

Inspected site

CPCSL Plasma, IncMinneapolis, United States

Inspection team

MDMelissa D Kalik

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.171Cited across public-safe Form 483 observations1x
21 CFR 630.10(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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