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Community Blood Center Dba Solvita FDA Inspection Record

FEI 3008808182 · Inspections, Form 483s, warning letters and import refusals

Community Blood Center Dba Solvita is an FDA-registered facility (FEI 3008808182) located in Kettering, OH, US. RegDataLab tracks 7 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 13, 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
4, latest Oct 9, 2021

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 13, 2024No Action Indicated (NAI)No citations listed
Mar 24, 2023No Action Indicated (NAI)No citations listed
Mar 12, 2020No Action Indicated (NAI)No citations listed
Jun 12, 2018No Action Indicated (NAI)No citations listed
Dec 8, 2015No Action Indicated (NAI)No citations listed
Dec 3, 2013No Action Indicated (NAI)No citations listed
Jan 24, 2012No 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 9, 2021Class IIB-0102-2022Skin
Skin, processed in a manner that could cause contamination or cross-contamination, was distributed.
Jan 23, 2020Class IIB-0423-2020Skin
Human skin allografts, where in-process controls were not followed allowing tissue to be processed in a manner that could cause…
Jan 23, 2017Class IIIB-0416-2017Bone
Bone allografts were inappropriately distributed.
Nov 7, 2014Class IIIB-0413-15Skin
Skin grafts, that did not meet release criteria, were distributed.

Facility details

Company
Community Blood Center
Location
Kettering, OH (US)
Source
device

FDA data resources

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