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Alliance Medical Passes Comprehensive FDA Directed Inspection.


PHOENIX -- Alliance Medical Corporation (Alliance), a leading reprocessor of single-use medical devices (SUDs), today announced that officials from the U.S. Food and Drug Administration (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.
) have completed a comprehensive directed inspection of the company's Phoenix, Arizona Phoenix /ˈfiːˌnɪks/ (English: Phoenix, Navajo: Hoozdo, lit. "the place is hot", Western Apache: Fiinigis) is the capital and the most populous city of the U.S.  facility and found that Alliance is in full compliance with the Quality System Regulations; Alliance was not issued a form 483 Notice of Inspectional Observations by FDA.

The inspection was directed from the Office of Compliance relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 the FDA's review of all Supplemental Validation Submissions (SVSs) on cleared 510(k) (premarket notifications) from reprocessing Reprocessing may refer to:
  • Nuclear reprocessing
  • Recycling
 companies as directed by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA MDUFMA Medical Device User Fee and Modernization Act ).

"Alliance is extremely proud that the inspection by the FDA was successful and we passed with flying colors Noun 1. flying colors - complete success; "they passed inspection with flying colors"
flying colours

success - an attainment that is successful; "his success in the marathon was unexpected"; "his new play was a great success"
," said Don Selvey, vice president of regulatory affairs and quality assurance. "This validates Alliance's commitment to working closely with the FDA to ensure that we are in full compliance with all regulations. As a leader in the reprocessing industry, Alliance strives to set the standard for safety and quality of reprocessed devices in order to help hospitals control spending without compromising patient care."

Alliance is one of the industry's most trusted device reprocessing companies, providing hands-on support for customers. Alliance employs clinically trained and experienced service technicians and account executives who utilize its clinically focused, three-phased client support program, Assessment, Implementation and Management (AIM), to set up and manage the most efficient and effective SUD SUD 1. Substance use disorder 2. Sudden unexpected or unexplained death. See Sudden unexplained nocturnal death.  reprocessing program. The savings healthcare facilities achieve as a result can be used for vital patient services, new medical technology and nursing salaries, all of which lead to improved patient care.

About Alliance Medical

Alliance Medical Corporation is a leading reprocessor of specific single-use medical devices (SUDs) and has safely reprocessed more than 12 million SUDs, saving hospitals and surgery centers in excess of $150 million. Alliance goes beyond providing technically superior medical device reprocessing services to deliver guaranteed maximum supply-cost savings to leading healthcare organizations. Alliance is differentiated by our unwavering partnership commitment, clinical implementation expertise and dedicated field associates which together ensure that we exceed our partner's goals and expectations. The Company's services focus on reducing supply costs of hospitals and surgery centers suffering from shrinking reimbursements and increasing costs. Alliance has agreements with leading national group purchasing organizations, alliances and supply chain service firms, including VHA VHA Veterans Health Administration
VHA Variable Housing Allowance
VHA Villages Homeowners Association
VHA Voluntary Hospitals Association
VHA Virtual Home Agent
VHA Very High Altitude
VHA Vapor Hazard Area
VHA Vermont Holstein-Friesian Association
, Broadlane and University HealthSystem Consortium (UHC UHC UnitedHealthcare
UHC United Health Care
UHC University Hospitals of Cleveland
UHC United Hitech Corporation
UHC Udvar-Hazy Center (National Air and Space Museum)
UHC University Health/System Consortium
UHC Unburned Hydrocarbons
), as well as a number of nationally recognized hospital integrated delivery networks, including Banner Health and Henry Ford Health System that collectively represent more than 4,000 healthcare facilities. For more information about Alliance Medical Corporation, visit www.alliance-medical.com; or call 888-888-3433.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Feb 2, 2005
Words:438
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