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Lifesouth Community Blood Centers Inc. - East Alabama Region FDA Inspection Record

FEI 1000524796 · Inspections, Form 483s, warning letters and import refusals

Lifesouth Community Blood Centers Inc. - East Alabama Region is an FDA-inspected facility (FEI 1000524796) located in Opelika, AL, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 26, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (3 VAI, 4 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
Form 483 and inspection documents
1 in FDA's reading room
Recalls as the recalling firm
1, latest May 16, 2006

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 26, 2025Voluntary Action Indicated (VAI)Testing of representative samples of reagent lots (21 CFR 606.65(c))
Following manufacturer's instructions (21 CFR 606.65(e))
QC procedures for supplies and reagents (21 CFR 606.100(b)(14))
Thorough investigations (21 CFR 606.100(c))
Jul 17, 2019Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Apr 11, 2017No Action Indicated (NAI)No citations listed
Jun 4, 2015No Action Indicated (NAI)No citations listed
Jul 16, 2013No Action Indicated (NAI)No citations listed
Aug 9, 2011No Action Indicated (NAI)No citations listed
Feb 13, 2009Voluntary 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
May 16, 2006Class IIB-0901-08Fresh Frozen Plasma
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Mar 26, 2025, which is not always the inspection or issue date. Published by FDA Oct 26, 2026.

FDA record score

8 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.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 26, 20256 x 16
Inspection classified VAIJul 17, 20196 x 0.251.5
Inspection classified VAIFeb 13, 200910 years or older, so it adds no points0
Class II recall B-0901-08, this FEI as the recalling firmMay 16, 200610 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
Lifesouth Community Blood Centers Inc. - East Alabama Region
Location
Opelika, AL (US)
Source
inspections

FDA data resources

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