CAPA deficiencies related to in vitro diagnostics (IVDs) dominated a March 17 warning letter.CAPA CAPA California Alternate Performance Assessment CAPA Captaris, Inc (stock symbol) CAPA Confederation of Asian and Pacific Accountants CAPA Creative and Performing Arts (school) deficiencies related to in vitro diagnostics In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. (IVDs) dominated a March 17 warning letter issued by the Chicago District Office to Abbott Labs. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. said Abbott's CAPA system did not trend all incidents in a timely manner, delaying "corrective action for TDx/TDx/FLx Flecainide assay...for more than 10 months" after the firm learned of the issue. Halting marketing of the product did not address underlying issues, the agency asserted. CAPA dominated the issues raised in the Abbott warning letter. FDA also cited delays in entering nonconforming material reports (NCMRs) for Auszyme into the CAPA system; delays in writing and entering an NCMR NCMR National Conference on Media Reform NCMR National Center for Marine Research NCMR National Center for Microgravity Research NCMR National Conference on Manufacturing Research NCMR Non-Conforming Material Report for an AxSYM Total Prostate Specific Antigen PSA (Prostate specific antigen) A tumor marker associated with prostate cancer. Mentioned in: Tumor Markers (PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. ) conjugate process validation failure and PSA IMx microparticle con-centrate microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. specification failure; not entering lots that failed protein testing early in processing; not assigning a hold time to bulk Auszyme monoclonal conjugate despite the conclusions of failure investigations; and a stability SOP that did not address creating an NCMR for stability failures. FDA found no documentation that management reviewed and approved a decision not to alert AxSYM users to a software defect causing incorrect test results. In addition, repeat testing and management review at the North Chicago firm did not address unit test failures identified during design verification testing for an Abbott Commander software version, the agency said. Further is-sues involved inadequate process validation and failure of the CAPA to reference the procedure for electronically changing a material disposition to "on hold" status. PMAs, PLAs and export certificates will not be approved until the violations are corrected, FDA stated. The agency said a reinspection was necessary to verify that Abbott's corrective actions were adequate. A company spokes-man said in an interview that Abbott was continuing to work with FDA on the issues covered in the letter. The audit occurred Sept. 8-Nov. 4, 1998. CAPA, Design, Stab, Val |
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