FDA-Inspected Site

LifeSouth Community Blood Centers, Inc

15 FDA inspections are on record for LifeSouth Community Blood Centers, Inc in Gainesville, United States.

483· Form 483 issued

Gainesville, United States · Last updated July 9, 2026

Overview

  • 15 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-21.

At a glance

Inspections

15

Form 483s

8

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 May 2026 – 21 May 2026Biologics483View 483 →
9 Sep 2024 – 12 Sep 2024BiologicsClean
1 Nov 2023 – 9 Nov 2023Medical Devices & Rad Health483View 483 →
29 Aug 2022 – 8 Sep 2022BiologicsClean
21 Feb 2020 – 27 Feb 2020Biologics483On file
17 Jul 2018 – 24 Jul 2018Biologics483View 483 →
11 Dec 2017 – 15 Dec 2017BiologicsClean
19 Jul 2016 – 25 Jul 2016Biologics483On file
7 Sep 2015 – 11 Sep 2015BiologicsClean
9 Sep 2014 – 16 Sep 2014Biologics483On file
8 Jul 2013 – 12 Jul 2013Biologics483View 483 →
4 Oct 2011Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

21 May 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Ivan E Reyes, Nerming V Briones

21 May 2026
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Ivan E Reyes, Nerming V Briones

9 Nov 2023
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Barbara T Carmichael

9 Nov 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Barbara T Carmichael

9 Nov 2023
21 CFR 820.100(b)

Documentation

Cited by Barbara T Carmichael

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations5x
21 CFR 820.22Cited across public-safe Form 483 observations3x
21 CFR 820.70(i)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 600.14(c)Cited across public-safe Form 483 observations1x
21 CFR 601.12(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 606.160(b)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited across public-safe Form 483 observations1x
21 CFR 610.60Cited across public-safe Form 483 observations1x
21 CFR 640.25(a)Cited across public-safe Form 483 observations1x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.20(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.20(e)Cited across public-safe Form 483 observations1x
21 CFR 820.25(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(e)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x
21 CFR 820.86Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind LifeSouth Community Blood Centers, Inc's 8 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat