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CSL Plasma Inc. FDA Inspection Record

FEI 3011813573 · Inspections, Form 483s, warning letters and import refusals

CSL Plasma Inc. is an FDA-inspected facility (FEI 3011813573) located in Philadelphia, PA, US. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 27, 2025: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
3, latest Mar 16, 2020

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 27, 2025No Action Indicated (NAI)No citations listed
May 2, 2019Voluntary Action Indicated (VAI)Responsible physician not on site - SP & plasmapheresis (21 CFR 630.5(c)(1)(i))
Jul 27, 2018No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Mar 16, 2020Class IIB-0513-2020Source Plasma
Source Plasma, collected in a manner that resulted in the test sample possibly being diluted with saline, was distributed.
Jul 18, 2019Class IIIB-0053-2020Source Plasma
Further Manufacturing
Feb 28, 2019Class IIIB-0491-2019Source Plasma
Source Plasma, collected from a donor for whom donor suitability was not adequately determined, was distributed.

FDA record score

3 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

2 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMay 2, 20196 x 0.251.5
Class II recall B-0513-2020, this FEI as the recalling firmMar 16, 20204 x 0.251

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
CSL Plasma Inc.
Location
Philadelphia, PA (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.