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CSL Behring GmbH FDA Inspection Record

FEI 3003098680 · Inspections, Form 483s, warning letters and import refusals

CSL Behring GmbH is an FDA-registered facility (FEI 3003098680) located in Hesse, DE. Registered operations: MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 18, 2026: Voluntary Action Indicated (VAI)
Inspections on record
5 (5 VAI)
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
Form 483 and inspection documents
3 in FDA's reading room
Recalls as the recalling firm
9, latest Mar 2, 2020
Import refusals
5

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
Feb 18, 2026Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Changes to Procedures Not Reviewed, Approved (21 CFR 211.100(a))
Procedures to be written and followed (21 CFR 211.198(a))
and 1 more
Mar 4, 2022Voluntary Action Indicated (VAI)No citations listed
May 17, 2016Voluntary Action Indicated (VAI)No citations listed
Jan 27, 2012Voluntary Action Indicated (VAI)No citations listed
Mar 18, 2010Voluntary Action Indicated (VAI)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 2, 2020Class IIZ-1790-2020Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient…
Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15…
Oct 7, 2019Class IIIB-0140-2020Antihemophilic Factor (Human)
Lots of Humate-P with misaligned labeling on the folding box, was distributed.
Apr 5, 2019Class IIIB-0653-2019Prothrombin Complex Concentrate (Human)
Misbranded Kcentra lot was distributed.
Jun 4, 2018Class IIB-0062-2019Prothrombin Complex Concentrate (Human)
Prothrombin Complex Concentrate (Human) Kcentra¿ 1000 U, with a potential risk of breakage of the glass vials, was distributed.
May 31, 2018Class IIZ-2931-2018N Latex CDT Kit
Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the…
Mar 22, 2018Class IIB-0061-2019Prothrombin Complex Concentrate (Human)
Three lots of Prothrombin Complex Concentrate (Human) Kcentra¿ 1000 U, with a potential risk of breakage of the glass vials, were…
Jun 5, 2017Class IIZ-0190-2018SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code… and 1 more product
Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human…
May 17, 2016Class IIZ-2241-2016Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878…
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7)…
Mar 18, 2016Class IIIB-0566-16Prothrombin Complex Concentrate (Human)
Two batches of Prothrombin Complex Concentrate (Human), not meeting incoming material specifications, were distributed.

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Feb 18, 2026, which is not always the inspection or issue date. Published by FDA Jul 22, 2026.
  • 483 on FDA.gov
    Inspection Apr 15, 2024 to Apr 18, 2024, issued Apr 18, 2024 (dates printed on the document). FDA listing date Apr 18, 2024. Published by FDA Apr 3, 2026.
  • 483 on FDA.gov
    FDA listing date Apr 18, 2024, which is not always the inspection or issue date. Published by FDA Oct 20, 2026.

FDA record score

15 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 15, 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.

11 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIFeb 18, 20266 x 16
Inspection classified VAIMar 4, 20226 x 0.63.6
Class II recall Z-1790-2020, this FEI as the recalling firmMar 2, 20204 x 0.251
Class II recall B-0062-2019, this FEI as the recalling firmJun 4, 20184 x 0.251
Class II recall Z-2931-2018, this FEI as the recalling firmMay 31, 20184 x 0.251
Class II recall B-0061-2019, this FEI as the recalling firmMar 22, 20184 x 0.251
Class II recall Z-0190-2018, this FEI as the recalling firmJun 5, 20174 x 0.251
Class II recall Z-2241-2016, this FEI as the recalling firmMay 17, 201610 years or older, so it adds no points0
Inspection classified VAIMay 17, 201610 years or older, so it adds no points0
Inspection classified VAIJan 27, 201210 years or older, so it adds no points0
Inspection classified VAIMar 18, 201010 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 Behring GmbH
Location
Hesse (DE)
Registration Expires
Dec 31, 2027
Operations
MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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