LifeSouth Community Blood Centers, Inc

FDA establishment 3003707120, Gainesville, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.

Inspections: 12
Official action indicated: 0
Last inspection ended: May 21, 2026
Warning letters: 0
Recalls since 2016: 25

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

02019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

12 inspections, newest first

Ended	Product and area	Citations	Classification
May 21, 2026	Biologics · Human Cellular, Tissue, and Gene Therapies	2 cited references 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. 21 CFR 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.	Voluntary Action Indicated (VAI)
Sep 12, 2024	Biologics · Human Cellular, Tissue, and Gene Therapies	None posted	No Action Indicated (NAI)
Nov 9, 2023	Devices · Postmarket Assurance: DevicesBiologics · Blood and Blood Products	10 cited references 21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented. 21 CFR 820.20(b)(3). Management representative No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system. 21 CFR 820.25(a). Personnel Personnel do not have the necessary training to perform their jobs. 21 CFR 803.17(a)(2). Lack of System for Determining MDR Events The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting. 21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established. 21 CFR 820.70(i). Documentation of software validation Software validation activities and results for computers or automated data processing systems used as part of the quality system have not been adequately documented. 21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established. 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established. 21 CFR 820.30(g). Design validation - software validation documentation Results of the validation of the device software were not adequately documented. 21 CFR 820.30(g). Design validation - Risk analysis Results of the design risk analysis were not documented.	Voluntary Action Indicated (VAI)
Sep 8, 2022	Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Blood and Blood Products; Biologics · Vaccines and Allergenic Products	None posted	No Action Indicated (NAI)
Feb 27, 2020	Biologics · Human Cellular, Tissue, and Gene Therapies	None posted	Voluntary Action Indicated (VAI)
Jul 24, 2018	Biologics · Human Cellular, Tissue, and Gene Therapies	12 cited references 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. 21 CFR 600.14(c). When to report Biological product deviations were not reported within the 45 calendar day timeframe. 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing. 21 CFR 211.170(b). Reserve drug product sample quantity - all tests The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product. 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. 21 CFR 211.186(a). Master production and control records, procedure The preparation of your master production and control records was not described in a written procedure. 21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. 21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to review production records to assure that no errors have occurred. 21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. 21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. 21 CFR 610.60. Package label - small containers The container label is not capable of bearing a full label, but the package label does not include the address and license number of the manufacturer and the expiration date.	Voluntary Action Indicated (VAI)
Dec 15, 2017	Biologics · Blood and Blood Products	None posted	No Action Indicated (NAI)
Sep 11, 2015	Biologics · Blood and Blood Products	None posted	No Action Indicated (NAI)
Sep 16, 2014	Biologics · Human Cellular, Tissue, and Gene Therapies	None posted	Voluntary Action Indicated (VAI)
Jul 12, 2013	Biologics · Blood and Blood Products	4 cited references 21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed. 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established. 21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been established. 21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.	Voluntary Action Indicated (VAI)
Oct 4, 2011	Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies; Devices · Postmarket Assurance: Devices	16 cited references 21 CFR 601.12(b). Major changes to an approved application Failure to submit a supplement prior to distributing product made using the change. 21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented. 21 CFR 820.70(i). Validation of changes to automated process software Changes to software used as part of production and the quality system were not adequately validated before approval and issuance. 21 CFR 820.30(g). Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses. 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 and a failure of a lot or unit to meet any of its specifications. 21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report. 21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed. 21 CFR 640.25(a). Storage temps./agitation Failure to store platelets immediately after resuspension at 20 to 24 degrees Celsius with continuous gentle agitation. 21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to show test results so as to provide a complete history of the work performed. 21 CFR 820.20(e). Quality System Procedures Quality system procedures and instructions have not been established. 21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been established. 21 CFR 606.160(b). Required records Failure to maintain donor records. 21 CFR 820.70(i). Software validation for automated processes Software used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol. 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained, and implemented. 21 CFR 820.30(e). Design review - documentation The design review results, including , were not documented in the design history file. 21 CFR 820.86. Acceptance status The acceptance status of product was not maintained.	Voluntary Action Indicated (VAI)
Dec 9, 2010	Biologics · Blood and Blood Products	None posted	No Action Indicated (NAI)

Recalls

25 drug, device and biologic recalls since 2016, newest first; 0 Class I

Recalled product	Class	Classified
Apheresis Platelets, Leukocytes Reduced, Pathogen ReducedBiologic · B-0196-2026	Class II	Oct 29, 2025
Red Blood Cells, Leukocytes ReducedBiologic · B-0126-2026	Class III	Aug 15, 2025
Apheresis Platelets, Leukocytes ReducedBiologic · B-0120-2026	Class II	Jul 20, 2025
Apheresis Platelets, Leukocytes ReducedBiologic · B-0214-2026	Class II	May 17, 2025
Red Blood Cells, Leukocytes ReducedBiologic · B-0286-2025	Class III	Oct 18, 2024
Red Blood Cells, Leukocytes ReducedBiologic · B-0409-2024	Class II	May 17, 2024
Fresh Frozen PlasmaBiologic · B-0238-2025	Class II	Feb 10, 2024
Apheresis Red Blood Cells, Leukocytes ReducedBiologic · B-0219-2023	Class II	Sep 26, 2022
Red Blood Cells, Leukocytes ReducedBiologic · B-0229-2023	Class II	Aug 16, 2022
Apheresis Red Blood Cells, Leukocytes ReducedBiologic · B-0080-2023	Class III	Jun 13, 2022
Red Blood Cells, Leukocytes ReducedBiologic · B-0052-2023	Class II	May 23, 2022
Blood and Blood Products for ReprocessingBiologic · B-0260-2022 · 2 products	Class II	Feb 11, 2022
Apheresis Red Blood Cells, Leukocytes ReducedBiologic · B-0193-2022	Class III	Nov 12, 2021
Red Blood Cells, Leukocytes ReducedBiologic · B-0551-2021	Class II	Jul 13, 2021
Apheresis Red Blood Cells, Leukocytes ReducedBiologic · B-0622-2021	Class III	Jul 6, 2021
Blood and Blood Products for ReprocessingBiologic · B-0544-2021	Class III	Jun 16, 2021
Red Blood Cells, Leukocytes ReducedBiologic · B-0448-2021	Class III	Apr 6, 2021
Red Blood Cells, Leukocytes ReducedBiologic · B-0115-2021 · 2 products	Class III	Oct 8, 2020
Red Blood Cells, Leukocytes ReducedBiologic · B-0048-2021	Class III	Sep 18, 2020
Red Blood Cells, Leukocytes ReducedBiologic · B-0128-2020 · 2 products	Class II	Aug 16, 2019
Red Blood Cells, Leukocytes ReducedBiologic · B-0832-2019	Class II	Jul 3, 2019
Red Blood Cells, Leukocytes ReducedBiologic · B-0183-2018	Class III	Oct 6, 2017
Red Blood Cells, Leukocytes ReducedBiologic · B-0015-2018	Class II	Aug 14, 2017
Red Blood Cells, Leukocytes ReducedBiologic · B-0716-2017	Class II	Apr 26, 2017
Red Blood Cells, Leukocytes ReducedBiologic · B-0657-16	Class II	Jun 30, 2016

Identifiers

FEI number: 3003707120
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports

Ended

Product and area

Citations

Classification

May 21, 2026

Biologics · Human Cellular, Tissue, and Gene Therapies

2 cited references

21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Voluntary Action Indicated (VAI)

Sep 12, 2024

Biologics · Human Cellular, Tissue, and Gene Therapies

None posted

No Action Indicated (NAI)

Nov 9, 2023

Devices · Postmarket Assurance: DevicesBiologics · Blood and Blood Products

10 cited references

21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented.
21 CFR 820.20(b)(3). Management representative No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
21 CFR 820.25(a). Personnel Personnel do not have the necessary training to perform their jobs.
21 CFR 803.17(a)(2). Lack of System for Determining MDR Events The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established.
21 CFR 820.70(i). Documentation of software validation Software validation activities and results for computers or automated data processing systems used as part of the quality system have not been adequately documented.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.30(g). Design validation - software validation documentation Results of the validation of the device software were not adequately documented.
21 CFR 820.30(g). Design validation - Risk analysis Results of the design risk analysis were not documented.

Voluntary Action Indicated (VAI)

Sep 8, 2022

Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Blood and Blood Products; Biologics · Vaccines and Allergenic Products

None posted

No Action Indicated (NAI)

Feb 27, 2020

Biologics · Human Cellular, Tissue, and Gene Therapies

None posted

Voluntary Action Indicated (VAI)

Jul 24, 2018

Biologics · Human Cellular, Tissue, and Gene Therapies

12 cited references

21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 600.14(c). When to report Biological product deviations were not reported within the 45 calendar day timeframe.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
21 CFR 211.170(b). Reserve drug product sample quantity - all tests The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.186(a). Master production and control records, procedure The preparation of your master production and control records was not described in a written procedure.
21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to review production records to assure that no errors have occurred.
21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 610.60. Package label - small containers The container label is not capable of bearing a full label, but the package label does not include the address and license number of the manufacturer and the expiration date.

Voluntary Action Indicated (VAI)

Dec 15, 2017

Biologics · Blood and Blood Products

None posted

No Action Indicated (NAI)

Sep 11, 2015

Biologics · Blood and Blood Products

None posted

No Action Indicated (NAI)

Sep 16, 2014

Biologics · Human Cellular, Tissue, and Gene Therapies

None posted

Voluntary Action Indicated (VAI)

Jul 12, 2013

Biologics · Blood and Blood Products

4 cited references

21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been established.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.

Voluntary Action Indicated (VAI)

Oct 4, 2011

Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies; Devices · Postmarket Assurance: Devices

16 cited references

21 CFR 601.12(b). Major changes to an approved application Failure to submit a supplement prior to distributing product made using the change.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
21 CFR 820.70(i). Validation of changes to automated process software Changes to software used as part of production and the quality system were not adequately validated before approval and issuance.
21 CFR 820.30(g). Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.
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 and a failure of a lot or unit to meet any of its specifications.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 640.25(a). Storage temps./agitation Failure to store platelets immediately after resuspension at 20 to 24 degrees Celsius with continuous gentle agitation.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to show test results so as to provide a complete history of the work performed.
21 CFR 820.20(e). Quality System Procedures Quality system procedures and instructions have not been established.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been established.
21 CFR 606.160(b). Required records Failure to maintain donor records.
21 CFR 820.70(i). Software validation for automated processes Software used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained, and implemented.
21 CFR 820.30(e). Design review - documentation The design review results, including , were not documented in the design history file.
21 CFR 820.86. Acceptance status The acceptance status of product was not maintained.