FDA-Inspected Site

CSL Plasma Inc.

1 FDA inspection is on record for CSL Plasma Inc. in South Portland, United States.

483· Form 483 issued

South Portland, United States · Last updated July 11, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2021-12-15.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Dec 2021 – 15 Dec 2021Biologics483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

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

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

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 site report

Get the verbatim findings behind CSL Plasma Inc.'s 1 Form 483

Recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat