FDA establishment 1771995, Colorado Springs, Colorado, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 630.30(a)(3). Donor medical history Failure to determine the suitability of a donation of blood and blood components based on whether the donor was free from factors that make the donor ineligible to donate.
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 630.30(b)(1). Unsuitable donation - release Failure to prevent the release of unsuitable blood and blood components for transfusion.
21 CFR 606.100(c). Record review prior to release All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.
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 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection and processing of blood and blood components for allogeneic transfusion were not always maintained and followed.
21 CFR 606.60(a). Provide proper equipment to meet requirements Failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in 21 CFR 606.
Voluntary Action Indicated (VAI)
Mar 31, 2015
Biologics · Blood and Blood Products
12 cited references
21 CFR 606.160(e)(1). Donor deferral record - each location A record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be distributed.
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 and autologous transfusion are not always maintained and followed.
21 CFR 211.150(b). Distribution Recall System The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
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 606.40(a)(1). Provide space for examination Failure to provide adequate space for private examinations of individuals to determine their suitability as blood donors.
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.
21 CFR 600.15. Blood & Blood Components Failure to maintain temperatures during shipment of Whole Blood as required.
21 CFR 606.121(f). Labeling of blood products unsuitable for transfusion Failure to prominently label blood and blood components (except for recovered plasma) determined to be unsuitable for transfusion with "NOT FOR TRANSFUSION" and the reason the unit is considered unsuitable.
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). Written SOPs available for use by personnel Failure to make available written procedures for use by personnel in the areas where the procedures are performed.
21 CFR 640.61. Obtaining consent in an appropriate manner Failure to present the hazards and risks of plasmapheresis in such a manner that intelligent and informed consent can be given by the prospective Source Plasma donor.
Voluntary Action Indicated (VAI)
Nov 19, 2012
Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
7 cited references
21 CFR 606.100(b)(10). Controlling storage temperatures The standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage temperatures for all blood products and reagents
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 are not always maintained and followed.
21 CFR 600.15. Blood & Blood Components Failure to maintain temperatures during shipment of Whole Blood as required.
21 CFR 640.34(b). Fresh Frozen Plasma - storage requirements Failure to place plasma, separated from red blood cells and intended to be labeled Fresh Frozen Plasma, in a freezer within eight hours after phlebotomy at a temperature of -18 degrees Celsius or colder.
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection of blood or blood components are not adequate in training and experience, including professional training as necessary to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to identify the person performing the work and be as detailed as necessary so as to provide a complete history of the work performed.
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.
Voluntary Action Indicated (VAI)
Mar 3, 2011
Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Blood and Blood Products
10 cited references
21 CFR 640.34(b). Fresh Frozen Plasma - storage requirements Failure to place plasma, separated from red blood cells and intended to be labeled Fresh Frozen Plasma, in a freezer within eight hours after phlebotomy at a temperature of -18 degrees Celsius or colder.
21 CFR 606.100(b)(10). Controlling storage temperatures The standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage temperatures for all blood products and reagents
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 homologous transfusion and further manufacturing purposes are not always followed.
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 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection of blood or blood components are not adequate in training and experience, including professional training as necessary to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.
21 CFR 606.160(e)(1). Donor deferral record - each location A record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be distributed.
21 CFR 640.61. Explanation of hazards Failure to explain to the prospective Source Plasma donor the hazards of the plasmapheresis procedure.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
21 CFR 606.121(f). Labeling of blood products unsuitable for transfusion Failure to prominently label blood and blood components (except for recovered plasma) determined to be unsuitable for transfusion with "NOT FOR TRANSFUSION" and the reason the unit is considered unsuitable.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to include dates of the various entries, show test results, show the expiration date assigned to specific products, and be as detailed as necessary so as to provide a complete history of the work performed.
No Action Indicated (NAI)
Jun 30, 2009
Biologics · Blood and Blood Products
3 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 collection and processing of blood and blood components for homologous transfusion and autologous transfusion are not always followed.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to identify the person performing the work and be as detailed as necessary so as to provide a complete history of the work performed.
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
Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
