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.
Biologics · Human Cellular, Tissue, and Gene TherapiesBiologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jun 19, 2017
Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Jun 9, 2016
Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Aug 4, 2015
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
May 21, 2015
Biologics · Blood and Blood Products
4 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, processing, and distribution of blood and blood components for homologous transfusion, autologous transfusion, and further manufacturing purposes 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 and storage of each unit of blood and blood components so that all steps can be clearly traced.
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 and fully followed.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation of an unexplained discrepancy.
Voluntary Action Indicated (VAI)
Jun 25, 2014
Biologics · Blood and Blood Products
1 cited reference
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 are not always followed.
Voluntary Action Indicated (VAI)
Jun 14, 2013
Biologics · Blood and Blood Products
6 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, processing, compatibility testing, storage, and distribution of blood and blood components for homologous transfusion, autologous transfusion, and further manufacturing purposes are not always followed.
21 CFR 630.40(c). Documentation Failure to document that you have successfully notified a deferred donor.
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 640.3(a). Donor suitability not performed on day of collection Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained person under his supervision on the day of collection.
21 CFR 606.40. Clean & orderly Failure to maintain facilities in a clean and orderly manner.
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)
Dec 16, 2010
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 of each unit of blood and blood components so that all steps can be clearly traced.
21 CFR 610.40(b). One or more approved screening tests Blood or blood components were not tested for evidence of infection due to communicable disease agents in accordance with the manufacturer's instructions.
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 are not always followed.
21 CFR 211.194(a)(2). Laboratory Test Method Verification Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use.
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
Davenport, Iowa, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.