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LifeSouth Community Blood Centers, Inc. FDA Inspection Record

FEI 3006497349 · Inspections, Form 483s, warning letters and import refusals

LifeSouth Community Blood Centers, Inc. is an FDA-inspected facility (FEI 3006497349) located in Mobile, AL, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 7, 2025: 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
16, latest Aug 5, 2025

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
Apr 7, 2025No Action Indicated (NAI)No citations listed
Dec 15, 2022No Action Indicated (NAI)No citations listed
Jun 25, 2018Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Jan 8, 2016No Action Indicated (NAI)No citations listed
Aug 21, 2014Voluntary Action Indicated (VAI)Equipment calibration frequency (21 CFR 606.60(b))
Required records (21 CFR 606.160(b))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Jul 19, 2012No Action Indicated (NAI)No citations listed
Jan 28, 2010No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 16 recalls. 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
Aug 5, 2025Class IIB-0125-2026Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Platelets, Leukocytes Reduced, Irradiated, for which platelet yield did not meet specifications, were distributed.
Jul 29, 2025Class IIB-0123-2026Apheresis Platelets, Leukocytes Reduced
Apheresis Platelets, Leukocytes Reduced, for which platelet yield did not meet specifications, were distributed.
Apr 2, 2025Class IIB-0137-2026Apheresis Platelets, Leukocytes Reduced
Apheresis Platelets, Leukocytes Reduced, for which platelet yield did not meet specifications, were distributed.
Apr 2, 2025Class IIB-0141-2026Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell…
Mar 18, 2024Class IIB-0362-2024Apheresis Red Blood Cells, Leukocytes Reduced
Leukoreduced Apheresis Red Blood Cells, which were not tested for hematocrit, were distributed.
Jul 11, 2023Class IIB-0631-2023Apheresis Platelets, Leukocytes Reduced
Plateletpheresis product, for which the quality control testing for pH did not meet specifications, was distributed.
Aug 27, 2022Class IIB-0201-2023Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, in which the platelet yield did not meet specifications, were distributed.
Aug 10, 2022Class IIB-0087-2023Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, in which the platelet yield did not meet specifications, were distributed.
Aug 4, 2022Class IIB-0188-2023Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, in which the platelet yield did not meet specifications, were distributed.
Jul 8, 2021Class IIB-0532-2021Red Blood Cells, Leukocytes Reduced
Red Blood Cell product, collected from a donor who had previously tested reactive for Hepatitis C (HCV), was distributed.

FDA record score

34 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.

18 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0125-2026, this FEI as the recalling firmAug 5, 20254 x 14
Class II recall B-0123-2026, this FEI as the recalling firmJul 29, 20254 x 14
Class II recall B-0137-2026, this FEI as the recalling firmApr 2, 20254 x 14
Class II recall B-0141-2026, this FEI as the recalling firmApr 2, 20254 x 14
Class II recall B-0362-2024, this FEI as the recalling firmMar 18, 20244 x 0.62.4
Class II recall B-0631-2023, this FEI as the recalling firmJul 11, 20234 x 0.62.4
Class II recall B-0201-2023, this FEI as the recalling firmAug 27, 20224 x 0.62.4
Class II recall B-0087-2023, this FEI as the recalling firmAug 10, 20224 x 0.62.4
Class II recall B-0188-2023, this FEI as the recalling firmAug 4, 20224 x 0.62.4
Inspection classified VAIJun 25, 20186 x 0.251.5
Class II recall B-0532-2021, this FEI as the recalling firmJul 8, 20214 x 0.251
Class II recall B-0192-2021, this FEI as the recalling firmNov 5, 20204 x 0.251
Class II recall B-0050-2021, this FEI as the recalling firmOct 27, 20204 x 0.251
Class II recall B-0377-2017, this FEI as the recalling firmDec 2, 20164 x 0.251
Class II recall B-0251-16, this FEI as the recalling firmJan 23, 201510 years or older, so it adds no points0
Inspection classified VAIAug 21, 201410 years or older, so it adds no points0
Class II recall B-2125-13, this FEI as the recalling firmMar 26, 201310 years or older, so it adds no points0
Class II recall B-1272-13, this FEI as the recalling firmDec 11, 201210 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
Mobile, AL (US)
Source
inspections

FDA data resources

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