Atlas

Form 483

CSL Plasma Inc. Form 483, 2021-12-15

FDA issued a Form 483 to CSL Plasma Inc. on 2021-12-15 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

CSL Plasma Inc. · South Portland, United States · Issued December 15, 2021

Overview

  • 4 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.

15 Dec 2021
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Alice C Silva

15 Dec 2021
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Alice C Silva

15 Dec 2021
21 CFR 606.40(a)(1)

Provide space for examination

Cited by Alice C Silva

15 Dec 2021
21 CFR 606.40(a)(1)

Provide space for examination

Cited by Alice C Silva

Inspected site

CPCSL Plasma Inc.South Portland, United States

Inspection team

ACAlice C Silva

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations2x
21 CFR 606.40(a)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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