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Lifesouth Community Blood Centers - Montgomery Region FDA Inspection Record

FEI 3000203326 · Inspections, Form 483s, warning letters and import refusals

Lifesouth Community Blood Centers - Montgomery Region is an FDA-inspected facility (FEI 3000203326) located in Montgomery, AL, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 14, 2025: Voluntary Action Indicated (VAI)
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
Form 483 and inspection documents
1 in FDA's reading room
Recalls as the recalling firm
107, latest Dec 12, 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 14, 2025Voluntary Action Indicated (VAI)Arm preparation (21 CFR 640.4(f))
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))
and 1 more
Apr 13, 2023No Action Indicated (NAI)No citations listed
Jul 24, 2019No Action Indicated (NAI)No citations listed
Aug 26, 2016No Action Indicated (NAI)No citations listed
Jul 21, 2014No Action Indicated (NAI)No citations listed
Nov 9, 2011Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Thorough investigations (21 CFR 606.100(c))
Sep 30, 2011No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 107 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
Dec 12, 2025Class IIB-0197-2026Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced
Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced, for which platelet yield did not meet specifications, were distributed.
Jul 22, 2025Class IIB-0122-2026Apheresis Platelets, Leukocytes Reduced
Apheresis Platelets, Leukocytes Reduced, for which platelet yield did not meet specifications, were distributed.
Jun 21, 2025Class IIB-0220-2026Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Platelets, Leukocytes Reduced, Irradiated product, for which platelet yield did not meet specifications, was distributed.
Nov 14, 2024Class IIB-0170-2025Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, in which the platelet yield did not meet specifications, were distributed.
Jul 15, 2024Class IIB-0004-2025Apheresis Red Blood Cells, Leukocytes Reduced
Leukoreduced Apheresis Red Blood Cells, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were…
Jul 7, 2023Class IIIB-0032-2024Red Blood Cells, Leukocytes Reduced
Misbranded Red Blood Cell product was distributed.
May 3, 2023Class IIB-0485-2023Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, with a pH below the expected value, were distributed.
Jan 20, 2023Class IIB-0301-2023Apheresis Platelets, Leukocytes Reduced, Irradiated
Leukoreduced Apheresis Platelets, Irradiated, with a pH value lower than acceptable, were distributed.
Nov 18, 2022Class IIB-0124-2023Apheresis Platelets, PAS, Leukocytes Reduced
Leukoreduced Apheresis Platelets, PAS, with a pH lower than the expected value, were distributed.
Jul 8, 2022Class IIB-0053-2023Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, in which the platelet yield did not meet specifications, were distributed.

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Apr 14, 2025, which is not always the inspection or issue date. Published by FDA Oct 30, 2026.

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 - Montgomery Region
Location
Montgomery, AL (US)
Source
inspections

FDA data resources

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