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LifeSouth Community Blood Centers, Inc FDA Inspection Record

FEI 3001451318 · Inspections, Form 483s, warning letters and import refusals

LifeSouth Community Blood Centers, Inc is an FDA-inspected facility (FEI 3001451318) located in Gainesville, GA, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Aug 12, 2026: No Action Indicated (NAI)
Inspections on record
7 (2 VAI, 5 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
3, latest Jun 20, 2008

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
Aug 12, 2026No Action Indicated (NAI)No citations listed
Feb 7, 2024Voluntary Action Indicated (VAI)Equipment calibration frequency (21 CFR 606.60(b))
Provide space for examination (21 CFR 606.40(a)(1))
Apr 11, 2019No Action Indicated (NAI)No citations listed
Feb 3, 2017No Action Indicated (NAI)No citations listed
Apr 24, 2015No Action Indicated (NAI)No citations listed
Mar 27, 2013Voluntary Action Indicated (VAI)Required records (21 CFR 606.160(b))
Storage temperatures after collection (21 CFR 640.4(h))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Apr 11, 2011No Action Indicated (NAI)Adverse Reaction - Investigations (21 CFR 606.170(a))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))

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
Jun 20, 2008Class IIB-0744-15Platelets Pheresis Leukocytes Reduced
Blood product, which did not meet acceptable product specifications, was distributed
Oct 5, 2005Class IIB-0071-08Platelets Pheresis Leukocytes Reduced
Blood product, with a low pH, was distributed.
May 31, 2005Class IIB-0743-15Red Blood Cells
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.

FDA record score

4 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.

5 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIFeb 7, 20246 x 0.63.6
Inspection classified VAIMar 27, 201310 years or older, so it adds no points0
Class II recall B-0744-15, this FEI as the recalling firmJun 20, 200810 years or older, so it adds no points0
Class II recall B-0071-08, this FEI as the recalling firmOct 5, 200510 years or older, so it adds no points0
Class II recall B-0743-15, this FEI as the recalling firmMay 31, 200510 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
Location
Gainesville, GA (US)
Source
inspections

FDA data resources

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