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FDA establishment 1070630, Madisonville, Kentucky, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 9
Official action indicated: 1
Last inspection ended: Apr 24, 2025
Warning letters: 0
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 and processing of blood and blood components for allogeneic transfusion and further manufacturing purposes were not always established and followed.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation of an unexplained discrepancy.
Voluntary Action Indicated (VAI)
Jan 18, 2023
Biologics · Vaccines and Allergenic ProductsBiologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
May 14, 2019
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Mar 3, 2017
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Feb 13, 2015
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jan 31, 2014
Biologics · Blood and Blood Products
9 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, and storage of blood and blood components for homologous transfusion are not always followed.
21 CFR 640.25(b). Quality control Failure to test each month (of manufacture) four units prepared from different donors at the end of the storage period for platelet count, pH of not less than 6.0 measured at the storage temperature of the unit, and actual plasma volume.
21 CFR 640.31. Donor eligibility Failure to ensure that whole blood donors meet suitability criteria.
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection, processing, compatibility testing, storage, and distribution 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 610.47(a). Lookback System [Collecting Establishment] Failure to establish, maintain, and follow an appropriate system for HCV "lookback."
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 606.170(a). Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.
21 CFR 610.46(a). Lookback System [Collecting Establishment] Failure to establish, maintain, and follow an appropriate system for HIV "lookback."
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)
Oct 20, 2011
Biologics · Blood and Blood Products
None posted
Voluntary Action Indicated (VAI)
Feb 2, 2011
Biologics · Blood and Blood Products
9 cited references
21 CFR 630.40(b)(1). Deferred or not eligible Failure to notify the donor that the donor is deferred or determined not to be suitable.
21 CFR 211.68(b). Written record not kept of program and validation data A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
21 CFR 640.3(a)(1). Donor suitability procedures not followed Failure to follow and maintain standard procedures and methods for determining the suitability of a donor as a source of blood.
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(c). Thorough investigations Failure to perform a thorough investigation of an unexplained discrepancy.
21 CFR 640.31. Donor eligibility Failure to ensure that whole blood donors meet suitability criteria.
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.
21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded.
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.
Official Action Indicated (OAI)
Dec 18, 2008
Biologics · Blood and Blood Products
8 cited references
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection, processing, compatibility testing, storage, and distribution 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 606.100(a). SOP compliance Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640.
21 CFR 211.68(b). Written record not kept of program and validation data A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
21 CFR 640.25(b)(4). Corrective action Failure to take immediate corrective action and maintain a record of corrective action when the quality control testing for platelets does not meet the prescribed requirements.
21 CFR 606.160(b). Required records Failure to maintain storage and distribution records.
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 further manufacturing purposes are not always followed.
21 CFR 640.25(b). Quality control Failure to test each month (of manufacture) four units prepared from different donors at the end of the storage period for platelet count, pH of not less than 6.0 measured at the storage temperature of the unit, and actual plasma volume.
21 CFR 606.160(a)(1). Legibility and indelibility Records are not indelible.
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
Madisonville, Kentucky, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.