| Jun 27, 2025 | Biologics · Human Cellular, Tissue, and Gene Therapies | None posted | No Action Indicated (NAI) |
| Sep 26, 2024 | Biologics · Blood and Blood Products | 2 cited references- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the processing, storage and distribution of blood and blood components for allogeneic transfusion were not always established, maintained and followed.
- 21 CFR 606.140(a). Establishment of spec., standards, and test procedures Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.
| Voluntary Action Indicated (VAI) |
| Aug 19, 2022 | Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products | 2 cited references- 21 CFR 606.160(b). Required records Failure to maintain storage and distribution, 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 established, maintained and followed.
| Voluntary Action Indicated (VAI) |
| May 18, 2017 | Biologics · Blood and Blood Products | 4 cited references- 21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
- 21 CFR 606.100(b)(8). Methods for pre-transfusion testing The standard operating procedure fails to include a written description of pretransfusion testing, where pretransfusion testing is applicable, including precautions to be taken to identify accurately the recipient blood samples and crossmatched donor units.
- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the processing of blood and blood components for allogeneic transfusion were not always established, maintained and followed.
- 21 CFR 606.160(b). Required records Failure to maintain quality control and general records.
| Voluntary Action Indicated (VAI) |
| Apr 9, 2015 | 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 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 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection, and 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 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(a)(1). Legibility and indelibility Records are illegible and not indelible.
- 21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
- 21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report.
| Voluntary Action Indicated (VAI) |
| Mar 25, 2013 | Biologics · Blood and Blood Products | 7 cited references- 21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report.
- 21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection, and checking of automatic, mechanical, and electronic 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 distribution of blood and blood components for homologous transfusion and autologous transfusion are not always maintained and followed.
- 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 the specific recipient.
- 21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the processing, storage, and distribution of each unit of blood and blood components so that all steps can be clearly traced.
- 21 CFR 211.180(c). Records not made readily available to FDA Records associated with drug product production, control, and distribution and within the retention period for such records, were not made readily available for authorized inspection.
- 21 CFR 211.194(a)(8). Second person sign off Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness.
| Voluntary Action Indicated (VAI) |
| Jun 21, 2011 | Biologics · Blood and Blood Products | 3 cited references- 21 CFR 600.14(c). When to report Biological product deviations were not reported within the 45 calendar day timeframe.
- 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the processing and distribution of blood and blood components for homologous transfusion are not always followed.
- 21 CFR 820.75(a). Documentation Process validation activities and results have not been documented and approved.
| Voluntary Action Indicated (VAI) |
| Dec 31, 2008 | Biologics · Blood and Blood Products | 3 cited references- 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 640.3(a)(1). Donor suitability procedures not followed Failure to follow standard procedures and methods for determining the suitability of a donor as a source of blood.
- 21 CFR 820.75(a). Documentation - specific items Documentation of process validation activities and results does not include the date and signature of the individuals approving the validation.
| Voluntary Action Indicated (VAI) |
| Dec 19, 2008 | Biologics · Blood and Blood Products | 2 cited references- 21 CFR 640.3(a)(1). Donor suitability procedures not followed Failure to follow standard procedures and methods for determining the suitability of a donor as a source of 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 of blood and blood components for homologous transfusion and further manufacturing purposes are not always followed.
| Voluntary Action Indicated (VAI) |
