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LifeSouth Community Blood Centers, Inc FDA Inspection Record

FEI 3003707120 · Inspections, Form 483s, warning letters and import refusals

LifeSouth Community Blood Centers, Inc is an FDA-registered facility (FEI 3003707120) located in Gainesville, FL, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 12 FDA inspections at this facility.

What FDA found at this site

Latest inspection
May 21, 2026: Voluntary Action Indicated (VAI)
Inspections on record
12 (7 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
83, latest Oct 29, 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

Showing the 10 most recent of 12 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 21, 2026Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Cleaning SOPs/instructions (21 CFR 211.67(b)(3))
Sep 12, 2024No Action Indicated (NAI)No citations listed
Nov 9, 2023Voluntary Action Indicated (VAI)Design validation - software validation documentation (21 CFR 820.30(g))
Design validation - Risk analysis (21 CFR 820.30(g))
Quality audits - Lack of or inadequate procedures (21 CFR 820.22)
Lack of or inadequate procedures (21 CFR 820.100(a))
and 6 more
Sep 8, 2022No Action Indicated (NAI)No citations listed
Feb 27, 2020Voluntary Action Indicated (VAI)No citations listed
Jul 24, 2018Voluntary Action Indicated (VAI)Authority lacking to review records, investigate errors (21 CFR 211.22(a))
Procedures not in writing, fully followed (21 CFR 211.22(d))
Computer control of master formula records (21 CFR 211.68(b))
Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
and 8 more
Dec 15, 2017No Action Indicated (NAI)No citations listed
Sep 11, 2015No Action Indicated (NAI)No citations listed
Sep 16, 2014Voluntary Action Indicated (VAI)No citations listed
Jul 12, 2013Voluntary Action Indicated (VAI)Design control - no procedures (21 CFR 820.30(a))
Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
Lack of or inadequate procedures (21 CFR 820.100(a))
Quality Audit/Reaudit - conducted (21 CFR 820.22)

Recalls

Showing the 10 most recent of 83 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
Oct 29, 2025Class IIB-0196-2026Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced
Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced, for which platelet yield did not meet specifications, were distributed.
Aug 15, 2025Class IIIB-0126-2026Red Blood Cells, Leukocytes Reduced
Red Blood Cells, Leukocytes Reduced, which were not labeled as containing red blood cell antibodies, were distributed.
Jul 20, 2025Class IIB-0120-2026Apheresis Platelets, Leukocytes Reduced
Apheresis Platelets, Leukocytes Reduced, for which platelet yield did not meet specifications, were distributed.
May 17, 2025Class IIB-0214-2026Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets product, for which platelet yield did not meet specifications, was distributed.
Oct 18, 2024Class IIIB-0286-2025Red Blood Cells, Leukocytes Reduced
Misbranded Leukoreduced Red Blood Cells, were distributed.
May 17, 2024Class IIB-0409-2024Red Blood Cells, Leukocytes Reduced
Red Blood Cell products, for which routine testing/testing performed, interpreted, documented, or labeled incorrectly, were distributed.
Feb 10, 2024Class IIB-0238-2025Fresh Frozen Plasma
Fresh Frozen Plasma products, collected from a donor who was not deferred for the appropriate time period for high risk behavior, were…
Sep 26, 2022Class IIB-0219-2023Apheresis Red Blood Cells, Leukocytes Reduced
Leukoreduced Apheresis Red Blood Cells, which did not meet the acceptable net red cell volume, were distributed.
Aug 16, 2022Class IIB-0229-2023Red Blood Cells, Leukocytes Reduced
Leukoreduced Red Blood Cells, manufactured greater than 72 hours post collection, were distributed.
Jun 13, 2022Class IIIB-0080-2023Apheresis Red Blood Cells, Leukocytes Reduced
Leukoreduced Apheresis Red Blood Cells, which did not meet the minimum requirement for Red Blood Cell recovery following leukoreduction…

FDA record score

43 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.

59 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMay 21, 20266 x 16
Class II recall B-0196-2026, this FEI as the recalling firmOct 29, 20254 x 14
Class II recall B-0120-2026, this FEI as the recalling firmJul 20, 20254 x 14
Class II recall B-0214-2026, this FEI as the recalling firmMay 17, 20254 x 14
Inspection classified VAINov 9, 20236 x 0.63.6
Class II recall B-0409-2024, this FEI as the recalling firmMay 17, 20244 x 0.62.4
Class II recall B-0238-2025, this FEI as the recalling firmFeb 10, 20244 x 0.62.4
Class II recall B-0219-2023, this FEI as the recalling firmSep 26, 20224 x 0.62.4
Class II recall B-0229-2023, this FEI as the recalling firmAug 16, 20224 x 0.62.4
Class II recall B-0052-2023, this FEI as the recalling firmMay 23, 20224 x 0.62.4
Class II recall B-0260-2022, this FEI as the recalling firmFeb 11, 20224 x 0.62.4
Inspection classified VAIFeb 27, 20206 x 0.251.5
Class II recall B-0551-2021, this FEI as the recalling firmJul 13, 20214 x 0.251
Class II recall B-0128-2020, this FEI as the recalling firmAug 16, 20194 x 0.251
Class II recall B-0832-2019, this FEI as the recalling firmJul 3, 20194 x 0.251
Class II recall B-0015-2018, this FEI as the recalling firmAug 14, 20174 x 0.251
Class II recall B-0716-2017, this FEI as the recalling firmApr 26, 20174 x 0.251
Inspection classified VAIJul 24, 2018Only the 3 most recent VAI inspections add points0
Class II recall B-0657-16, this FEI as the recalling firmJun 30, 201610 years or older, so it adds no points0
Class II recall B-0261-16, this FEI as the recalling firmDec 4, 201510 years or older, so it adds no points0
Inspection classified VAISep 16, 201410 years or older, so it adds no points0
Inspection classified VAIJul 12, 201310 years or older, so it adds no points0
Inspection classified VAIOct 4, 201110 years or older, so it adds no points0
Class II recall B-1115-08, this FEI as the recalling firmAug 21, 200710 years or older, so it adds no points0
Class II recall B-1074-08, this FEI as the recalling firmAug 17, 200710 years or older, so it adds no points0
Class II recall B-1073-08, this FEI as the recalling firmJul 18, 200710 years or older, so it adds no points0
Class II recall B-1114-08, this FEI as the recalling firmJul 3, 200710 years or older, so it adds no points0
Class II recall B-1127-08, this FEI as the recalling firmJun 25, 200710 years or older, so it adds no points0
Class II recall B-1078-08, this FEI as the recalling firmMay 22, 200710 years or older, so it adds no points0
Class II recall B-1097-08, this FEI as the recalling firmMay 18, 200710 years or older, so it adds no points0
Class II recall B-1077-08, this FEI as the recalling firmMar 9, 200710 years or older, so it adds no points0
Class II recall B-1079-08, this FEI as the recalling firmMar 9, 200710 years or older, so it adds no points0
Class II recall B-0179-7, this FEI as the recalling firmAug 16, 200610 years or older, so it adds no points0
Class II recall B-1360-08, this FEI as the recalling firmMar 4, 200610 years or older, so it adds no points0
Class II recall B-1369-08, this FEI as the recalling firmFeb 1, 200610 years or older, so it adds no points0
Class II recall B-0597-7, this FEI as the recalling firmOct 4, 200510 years or older, so it adds no points0
Class II recall B-0247-7, this FEI as the recalling firmSep 13, 200510 years or older, so it adds no points0
Class II recall B-0598-7, this FEI as the recalling firmSep 12, 200510 years or older, so it adds no points0
Class II recall B-0625-7, this FEI as the recalling firmSep 2, 200510 years or older, so it adds no points0
Class II recall B-0180-7, this FEI as the recalling firmAug 16, 200510 years or older, so it adds no points0
Class II recall B-1212-07, this FEI as the recalling firmJun 12, 200510 years or older, so it adds no points0
Class II recall B-0212-7, this FEI as the recalling firmMay 5, 200510 years or older, so it adds no points0
Class II recall B-0499-7, this FEI as the recalling firmApr 26, 200510 years or older, so it adds no points0
Class II recall B-0178-7, this FEI as the recalling firmMar 17, 200510 years or older, so it adds no points0
Class II recall B-0498-7, this FEI as the recalling firmMar 16, 200510 years or older, so it adds no points0
Class II recall B-0942-07, this FEI as the recalling firmFeb 7, 200510 years or older, so it adds no points0
Class II recall B-0851-07, this FEI as the recalling firmJan 24, 200510 years or older, so it adds no points0
Class II recall B-0436-7, this FEI as the recalling firmJan 13, 200510 years or older, so it adds no points0
Class II recall B-0133-5, this FEI as the recalling firmJun 24, 200410 years or older, so it adds no points0
Class II recall B-0129-5, this FEI as the recalling firmMay 18, 200410 years or older, so it adds no points0
Class II recall B-0130-5, this FEI as the recalling firmMay 6, 200410 years or older, so it adds no points0
Class II recall B-0123-5, this FEI as the recalling firmApr 21, 200410 years or older, so it adds no points0
Class II recall B-0134-5, this FEI as the recalling firmFeb 20, 200410 years or older, so it adds no points0
Class II recall B-1032-4, this FEI as the recalling firmNov 11, 200310 years or older, so it adds no points0
Class II recall B-0140-5, this FEI as the recalling firmOct 20, 200310 years or older, so it adds no points0
Class II recall B-0992-4, this FEI as the recalling firmOct 3, 200310 years or older, so it adds no points0
Class II recall B-0107-5, this FEI as the recalling firmAug 25, 200310 years or older, so it adds no points0
Class II recall B-1047-4, this FEI as the recalling firmAug 6, 200310 years or older, so it adds no points0
Class II recall B-0117-5, this FEI as the recalling firmJul 16, 200310 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, FL (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
both

FDA data resources

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