LifeSouth Community Blood Centers, Inc.

FDA establishment 1076458, Gainesville, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 7
Official action indicated: 0
Last inspection ended: Aug 18, 2025
Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

02019

12021

02023

12025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

7 inspections, newest first

Ended	Product and area	Citations	Classification
Aug 18, 2025	Biologics · Blood and Blood Products	1 cited reference 21 CFR 606.65(e). Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.	Voluntary Action Indicated (VAI)
Aug 19, 2021	Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products	None posted	No Action Indicated (NAI)
Apr 12, 2018	Biologics · Blood and Blood Products	None posted	No Action Indicated (NAI)
Apr 15, 2016	Biologics · Blood and Blood Products	None posted	No Action Indicated (NAI)
Sep 30, 2014	Biologics · Blood and Blood Products	4 cited references 21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy. 21 CFR 606.160(b). Required records Failure to maintain processing records. 21 CFR 211.68(a). Written calibration / inspection records not kept Records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained. 21 CFR 640.31. Donor eligibility Failure to ensure that donors meet suitability criteria.	Voluntary Action Indicated (VAI)
Oct 3, 2012	Biologics · Blood and Blood Products	2 cited references 21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report . 21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the collection, processing, storage, and distribution of each unit of blood and blood components so that all steps can be clearly traced.	Voluntary Action Indicated (VAI)
Apr 18, 2011	Biologics · Blood and Blood Products	None posted	No Action Indicated (NAI)

Identifiers

FEI number: 1076458
FDA firm profile: Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters