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FDA establishment 1772751, Fort Collins, Colorado, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 8
Official action indicated: 0
Last inspection ended: Jul 16, 2026
Warning letters: 0
Recalls since 2016: 2
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.
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 allogeneic transfusion were not always established, maintained and followed.
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 630.10(g)(1). Proof Of Identity Failure to obtain from the donor on the day of donation a postal address where the donor may be contacted for 8 weeks after donation.
Voluntary Action Indicated (VAI)
Jun 5, 2025
Biologics · Blood and Blood Products
2 cited references
21 CFR 606.170(b). Adverse reaction - fatality A confirmed, fatal complication of transfusion was not submitted in writing within 7 days after the fatality to the Director, Office of Compliance, Center for Biologics Evaluation and Research by the facility that performed the compatibility tests in the event of a transfusion reaction.
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.
Voluntary Action Indicated (VAI)
Sep 14, 2020
Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products
None posted
No Action Indicated (NAI)
Nov 15, 2017
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Nov 30, 2015
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 and processing and storage of blood and blood components for homologous transfusion are not always maintained and followed .
21 CFR 640.3(f). Donations in less than eight weeks A person served as a source of blood more than once in 8 weeks and was not examined at the time of donation and certified by a physician to be in good health as indicated in part in 21 CFR 640.3(b).
21 CFR 640.3(a)(1). Donor suitability procedures not followed Failure to maintain standard procedures and methods for determining the suitability of a donor as a source of blood.
21 CFR 640.61. Explanation of hazards Failure to explain to the prospective Source Plasma donor the hazards of the plasmapheresis procedure .
21 CFR 640.11(a). General requirements - storage Failure to store the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the collection of each unit of blood and blood components so that all steps can be clearly traced.
Voluntary Action Indicated (VAI)
Feb 26, 2014
Biologics · Blood and Blood Products
None posted
Voluntary Action Indicated (VAI)
Dec 14, 2011
Biologics · Blood and Blood Products
14 cited references
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 630.40(a). Notification Failure to make reasonable attempts to notify a donor who has been deferred based on the results of tests for evidence of communicable disease agent(s).
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.
21 CFR 640.120. Alternative procedures Failure to request from CBER and obtain approval for exceptions or alternatives to requirements regarding.
21 CFR 640.11(a). General requirements - storage Failure to maintain the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing.
21 CFR 640.31. Donor eligibility Failure to ensure that whole blood donors meet suitability criteria.
21 CFR 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies.
21 CFR 640.61. Explanation of hazards Failure to explain to the prospective Source Plasma donor the hazards of the plasmapheresis procedure.
21 CFR 640.4(h). Storage temperatures after collection After collection, blood is not immediately stored at a temperature between 1 and 6 degrees Celsius and transported from the donor clinic to the processing laboratory in temporary storage to cool the blood continuously toward a range between 1 and 6 degrees Celsius.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection, and checking of equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to identify the person performing the work, include dates of the various entries, show test results, and be as detailed as necessary so as to provide a complete history of the work performed.
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, storage, and distribution of blood and blood components for homologous transfusion and autologous transfusion are not always maintained and followed.
Voluntary Action Indicated (VAI)
Aug 19, 2010
Biologics · Blood and Blood Products
6 cited references
21 CFR 606.60(a). Equipment observed, standardized, calibrated Equipment used in the storage and distribution of blood and blood components is not standardized on a regularly scheduled basis as prescribed in the SOP Manual.
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 further manufacturing purposes are not always maintained, followed, and maintained on the premises.
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 606.160(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 606.171. 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 606.65(e). Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.
Voluntary Action Indicated (VAI)
Recalls
2 drug, device and biologic recalls since 2016, newest first; 0 Class I
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
Fort Collins, Colorado, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.