Community Blood Center, Inc. FDA Inspection Record

FEI 2172110 · Inspections, Form 483s, warning letters and import refusals

Community Blood Center, Inc. is an FDA-inspected facility (FEI 2172110) located in Wausau, WI, US. RegDataLab tracks 7 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Oct 22, 2024: 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
8, latest Oct 30, 2024

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
Oct 22, 2024No Action Indicated (NAI)No citations listed
Sep 17, 2019No Action Indicated (NAI)No citations listed
Aug 2, 2017No Action Indicated (NAI)No citations listed
Feb 12, 2015No Action Indicated (NAI)No citations listed
Aug 22, 2013No Action Indicated (NAI)No citations listed
Mar 23, 2011No Action Indicated (NAI)No citations listed
Mar 23, 2009No 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
Oct 30, 2024Class IIIB-0150-2025Pooled Cryoprecipitated AHF
Pooled Cryoprecipitated AHF, which was labeled with an incorrect volume, was distributed.
Sep 9, 2021Class IIIB-0038-2022Red Blood Cells, Leukocytes Reduced and 1 more product
Blood products, in which donor testing was not performed or incomplete, were distributed.
Jan 10, 2014Class IIB-0400-14Platelets Pheresis Leukocytes Reduced
Blood product, with a low platelet yield, was distributed.
Oct 1, 2013Class IIIB-0117-14Red Blood Cells Leukocytes Reduced
Blood products, labeled with incorrect or missing information, were distributed.
May 24, 2012Class IIB-2281-12Red Blood Cells Leukocytes Reduced and 1 more product
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Dec 17, 2008Class IIB-2054-12Red Blood Cells Leukocytes Reduced and 1 more product
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Nov 12, 2003Class IIB-0893-7Recovered Plasma
Donor Screening, donor gave history which warranted Blood product, collected from a donor who had received a body piercing within twelve…
Aug 10, 2000Class IIIB-2002-4Red Blood Cells
Blood products, collected in expired collection bags, were distributed.

Facility details

Company
Community Blood Center, Inc.
Location
Wausau, WI (US)
Source
inspections

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