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U.S. Department of Health and Human Services

Withdrawn ASCA Testing Laboratories
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This page lists testing laboratories who have either 1) voluntarily withdrawn their ASCA Accreditation or 2) have had their ASCA Accreditation withdrawn through an FDA-initiated process. See below for more details.

Notes:

  • Labs listed below with a status of "FDA Initiated Withdrawal" have had their ASCA Accreditation withdrawn as a result of failing to meet the requirements of the ASCA Program as detailed in Section 514(d) of the FD&C Act and the relevant ASCA guidance documents. For some labs listed with a status of "FDA Initiated Withdrawal," the FDA has identified data integrity concerns with testing conducted by the testing laboratory and submitted to the agency in premarket submissions.
  • Labs listed below with a status of "Voluntarily Withdrawn" have requested that their ASCA Accreditation be withdrawn voluntarily. This is often due to business decisions (e.g. closing of or moving the laboratory location, limited laboratory services, etc.).
  • See currently ASCA-accredited Test Labs here ASCA-Accredited Testing Laboratories

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    Test Lab: CSA Group Testing & Certification Inc. - Richmond [TL-50]
    Accreditation Status: Voluntarily Withdrawn - Start Date: 04/12/2021 - End Date: 02/13/2024
    Accreditation Body Organization Name: International Acccreditation Service, Inc. (IAS)
    Test Lab Primary Contact: John Sena, john.sena@csagroup.org, 13799 Commerce Parkway, Richmond British Columbia CA V6V 2N9
     
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    Exclusions
    Transition Inactive 12/17/2023 12-269
    		 60601-1-3 Edition 2.1 2013-04
    Transition Inactive 12/17/2023 19-14
    		 60601-1-11 Edition 2.0 2015-01
    Transition Inactive 12/17/2023 19-15
    		 60601-1-12 Edition 1.0 2014-06
    Transition Inactive 12/17/2023 19-16
    		 HA60601-1-11:2015
    Transition Inactive 12/17/2023 19-4
    		 ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
    Transition Inactive 12/17/2023 19-9
    		 60601-1-10 Edition 1.1 2013-11
    Transition Inactive 12/17/2023 5-76
    		 60601-1-8 Edition 2.1 2012-11
    Transition Inactive 12/17/2023 5-89
    		 60601-1-6 Edition 3.1 2013-10
    Transition Inactive 12/17/2023 6-387
    		 60601-2-50 Edition 2.1 2016-04
    Transition Inactive 12/17/2023 6-390
    		 80601-2-35 Edition 2.1 2016-04
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