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LifeSouth Community Blood Centers, Inc. - Marion Region FDA Inspection Record

FEI 1051733 · Inspections, Form 483s, warning letters and import refusals

LifeSouth Community Blood Centers, Inc. - Marion Region is an FDA-inspected facility (FEI 1051733) located in Ocala, FL, US. RegDataLab tracks 8 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 19, 2025: No Action Indicated (NAI)
Inspections on record
8 (1 VAI, 7 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
1, latest Jul 30, 2004

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
Feb 19, 2025No Action Indicated (NAI)No citations listed
May 10, 2023Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
May 20, 2019No Action Indicated (NAI)No citations listed
Jul 5, 2017No Action Indicated (NAI)No citations listed
Jul 13, 2015No Action Indicated (NAI)No citations listed
Jul 19, 2013No Action Indicated (NAI)No citations listed
Oct 31, 2011No Action Indicated (NAI)No citations listed
Nov 19, 2009No Action Indicated (NAI)No citations listed

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
Jul 30, 2004Class IIB-0605-5Red Blood Cells, Leukocytes Reduced and 1 more product
Blood products, that tested negative for Hepatitis B surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (andi-HBc)…

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.

2 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMay 10, 20236 x 0.63.6
Class II recall B-0605-5, this FEI as the recalling firmJul 30, 200410 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 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
LifeSouth Community Blood Centers, Inc. - Marion Region
Location
Ocala, FL (US)
Source
inspections

FDA data resources

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