| Mar 11, 2026 | Biologics · Blood and Blood Products | 3 cited references- 21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to identify the person performing the work so as to provide a complete history of the work performed.
- 21 CFR 606.160(b). Required records Failure to maintain quality control and general records.
- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the compatibility testing and distribution of blood and blood components for allogeneic transfusion were not always followed.
| Voluntary Action Indicated (VAI) |
| Jun 12, 2024 | Biologics · Human Cellular, Tissue, and Gene Therapies | None posted | No Action Indicated (NAI) |
| Apr 26, 2023 | Biologics · Blood and Blood Products | 3 cited references- 21 CFR 600.14(a)(1). Who must report - manufacturer Failure to submit a biological deviation report.
- 21 CFR 606.160(b). Required records Failure to maintain quality control and general records.
- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the storage and distribution of blood and blood components for allogeneic transfusion were not always followed.
| Voluntary Action Indicated (VAI) |
| Jul 20, 2022 | Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies; Biologics · Vaccines and Allergenic Products | 3 cited references- 21 CFR 1271.75(a)(1). Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
- 21 CFR 1271.50(a). Determination based on screening and testing HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
- 21 CFR 1271.47(a). Testing, screening, donor eligibility procedures You did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
| Voluntary Action Indicated (VAI) |
| Mar 12, 2020 | Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products; Biologics · Human Cellular, Tissue, and Gene Therapies | 1 cited reference- 21 CFR 1271.75(a)(1). Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
| Voluntary Action Indicated (VAI) |
| Jun 6, 2019 | Biologics · Blood and Blood Products | None posted | No Action Indicated (NAI) |
| Oct 16, 2017 | Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Blood and Blood Products | None posted | No Action Indicated (NAI) |
| Feb 8, 2017 | Biologics · Blood and Blood Products | 3 cited references- 21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to be as detailed as necessary so as to provide a complete history of the work performed.
- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection, processing, storage and distribution of blood and blood components for allogeneic transfusion were not always maintained and followed.
- 21 CFR 606.160(b). Required records Failure to maintain general records.
| Voluntary Action Indicated (VAI) |
| Feb 23, 2016 | Biologics · Human Cellular, Tissue, and Gene Therapies | 3 cited references- 21 CFR 1271.55(d)(2). Accurate, indelible, legible Donor eligibility records are not accurate , indelible and legible .
- 21 CFR 1271.75(c). Reproductive cells/ tissues- general Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not screened by a review of relevant medical records for of communicable diseases of the genitourinary tract.
- 21 CFR 1271.47(a). Procedures for all other requirements Procedures for all steps performed in the screening and determining of donor eligibility of HCT/Ps were not established , maintained , defined , documented , implemented and followed .
| Voluntary Action Indicated (VAI) |
| Mar 20, 2015 | Biologics · Blood and Blood Products | 4 cited references- 21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine checking of automatic equipment is not performed according to a written program designed to assure proper performance.
- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for homologous transfusion and autologous transfusion are not always maintained and followed.
- 21 CFR 606.160(b). Required records Failure to maintain quality control and general records.
- 21 CFR 640.4(f). Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
| Voluntary Action Indicated (VAI) |
| Oct 10, 2014 | Drugs · Bioresearch Monitoring | None posted | No Action Indicated (NAI) |
| Apr 7, 2014 | Biologics · Human Cellular, Tissue, and Gene Therapies | 3 cited references- 21 CFR 1271.47(a). Testing, screening, donor eligibility procedures Procedures for all steps performed in the screening and determining of donor eligibility of HCT/Ps were not established, maintained, defined, documented, implemented, and followed.
- 21 CFR 1271.55(d)(2). Accurate, indelible, legible Donor eligibility records are not accurate, indelible, and legible.
- 21 CFR 1271.75(c). Reproductive cells/ tissues- general Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not screened by a review of relevant medical records for risk factors of communicable diseases of the genitourinary tract.
| Voluntary Action Indicated (VAI) |
| Mar 5, 2013 | Biologics · Blood and Blood Products | 5 cited references- 21 CFR 606.140(c). Adequate identification and handling of test samples Failure to adequately provide for identification and handling of all test samples so that they are accurately related to its donor.
- 21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the collection and processing of each unit of blood and blood components so that all steps can be clearly traced.
- 21 CFR 211.194(a)(5). Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test.
- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection, processing, and distribution of blood and blood components for homologous transfusion are not always maintained and followed.
- 21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to identify the person performing the work so as to provide a complete history of the work performed.
| Voluntary Action Indicated (VAI) |
| Feb 3, 2012 | Biologics · Human Cellular, Tissue, and Gene Therapies | 3 cited references- 21 CFR 1271.75(a)(1). Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
- 21 CFR 1271.75(a)(2). Risks associated with xenotransplantation Donors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation.
- 21 CFR 1271.47(a). Procedures for all other requirements Procedures for all steps performed in the testing, screening, and determining of donor eligibility of HCT/Ps were not established, maintained, defined, documented, implemented, and followed.
| Voluntary Action Indicated (VAI) |
| Mar 23, 2011 | Biologics · Blood and Blood Products | 7 cited references- 21 CFR 606.160(b). Required records Failure to maintain quality control and general records.
- 21 CFR 640.4(f). Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.
- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection, processing, storage, and distribution of blood and blood components for homologous transfusion and autologous transfusion are not always maintained and followed.
- 21 CFR 640.11(a). General requirements - storage Failure to store and maintain the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing.
- 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 211.194(a)(5). Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test.
- 21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not justified.
| Voluntary Action Indicated (VAI) |
| Jun 2, 2009 | Biologics · Blood and Blood Products | 5 cited references- 21 CFR 803.18(a). Event files -- failure to establish and maintain MDR event files have not been established and maintained.
- 21 CFR 606.160(a)(1). Legibility and indelibility Records are illegible and not indelible.
- 21 CFR 803.17(b)(2). Reports and information documentation The written MDR procedure does not include documentation and recordkeeping requirements for all Medical Device Reports and information submitted to FDA and device manufacturers.
- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
- 21 CFR 640.25(b)(4). Corrective action Failure to maintain a record of corrective action when the quality control testing for platelets does not meet the prescribed requirements.
| Voluntary Action Indicated (VAI) |
| Mar 17, 2009 | Biologics · Human Cellular, Tissue, and Gene Therapies | None posted | Voluntary Action Indicated (VAI) |
Manhasset, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.