CSL Plasma Inc. FDA Inspection Record

FEI 1930460 · Inspections, Form 483s, warning letters and import refusals

CSL Plasma Inc. is an FDA-inspected facility (FEI 1930460) located in Kansas City, MO, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 21, 2025: No Action Indicated (NAI)
Inspections on record
7 (7 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
11, latest Jun 25, 2010

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 21, 2025No Action Indicated (NAI)No citations listed
Sep 17, 2018No Action Indicated (NAI)No citations listed
Dec 15, 2015No Action Indicated (NAI)No citations listed
Jul 23, 2014No Action Indicated (NAI)No citations listed
Jun 10, 2014No Action Indicated (NAI)No citations listed
Apr 22, 2011No Action Indicated (NAI)No citations listed
Sep 27, 2010No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 11 recalls. 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
Jun 25, 2010Class IIB-2532-12Source Plasma
Blood products, collected from a donor whose physical examination findings were not documented, were distributed.
Jan 28, 2010Class IIB-0034-13Source Plasma
Blood products, collected from deferred donors, were distributed.
Nov 25, 2009Class IIB-0149-13Source Plasma
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Nov 9, 2009Class IIB-2214-12Source Plasma
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Nov 7, 2009Class IIB-2216-12Source Plasma
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Nov 6, 2009Class IIB-0080-13Source Plasma
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Oct 21, 2009Class IIB-2215-12Source Plasma
Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
Aug 9, 2009Class IIIB-2363-12Source Plasma
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Nov 22, 2002Class IIB-1895-5Source Plasma
Source Plasma, collected from a donor who had received a piercing within 12 months of donation, was distributed.
Oct 25, 2002Class IIB-1855-5Source Plasma
Blood products, collected from a donor who had received a piercing within 12 months of donation, were distributed.

FDA record score

0 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.

10 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-2532-12, this FEI as the recalling firmJun 25, 201010 years or older, so it adds no points0
Class II recall B-0034-13, this FEI as the recalling firmJan 28, 201010 years or older, so it adds no points0
Class II recall B-0149-13, this FEI as the recalling firmNov 25, 200910 years or older, so it adds no points0
Class II recall B-2214-12, this FEI as the recalling firmNov 9, 200910 years or older, so it adds no points0
Class II recall B-2216-12, this FEI as the recalling firmNov 7, 200910 years or older, so it adds no points0
Class II recall B-0080-13, this FEI as the recalling firmNov 6, 200910 years or older, so it adds no points0
Class II recall B-2215-12, this FEI as the recalling firmOct 21, 200910 years or older, so it adds no points0
Class II recall B-1895-5, this FEI as the recalling firmNov 22, 200210 years or older, so it adds no points0
Class II recall B-1855-5, this FEI as the recalling firmOct 25, 200210 years or older, so it adds no points0
Class II recall B-1832-5, this FEI as the recalling firmSep 19, 200210 years or older, so it adds no points0

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
Kansas City, MO (US)
Source
inspections

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