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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Withdrawn ASCA Testing Laboratories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This page lists testing laboratories who have either 1) voluntarily withdrawn their ASCA Accreditation or 2) have had their ASCA Accreditation withdrawn through an FDA-initiated process.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  • Labs listed below with a status of "FDA Initiated Withdrawal" have had their ASCA Accreditation withdrawn as a result of failing to meet the requirements of the ASCA Program as detailed in Section 514(d) of the FD&C Act and the relevant ASCA guidance documents.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  • Labs listed below with a status of "Voluntarily Withdrawn" have requested that their ASCA Accreditation be withdrawn voluntarily.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: SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch [TL-77]
    Accreditation Status: FDA Initiated Withdrawal - Start Date: 06/24/2021 - End Date: 05/01/2025
    Accreditation Body Organization Name: National Voluntary Laboratory Accreditation Program (NVLAP)
    Test Lab Primary Contact: Bonnie Liao, Bonnie.liao@sgs.com, No. 198 of Kezhu Road, Science Park, Guangzhou Economic & Technology Development District, Guangzhou Guangdong CN
     
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    Designation Number
    Exclusions
    Transition Inactive 07/07/2024 1-115
    		 80601-2-70 First Edition 2015-01-15
    Transition Inactive 12/17/2023 1-102
    		 80601-2-69 First edition 2014-07-15
    Transition Inactive 12/17/2023 12-269
    		 60601-1-3 Edition 2.1 2013-04
    Transition Inactive 12/17/2023 12-310
    		 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION
    Transition Inactive 12/17/2023 12-311
    		 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION
    Transition Inactive 12/17/2023 12-317
    		 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
    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 19-8
    		 60601-1-2 Edition 4.0 2014-02
    Accreditation excludes Figure 3, "nursing homes" as an example of the HOME HEALTHCARE ENVIRONMENT, Subclause 8.9, Table 8 on Page 39: The citation of Note Select to expand and show more 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 6-385
    		 60601-2-19 Edition 2.1 2016-04
    Transition Inactive 12/17/2023 6-387
    		 60601-2-50 Edition 2.1 2016-04
    Transition Inactive 12/17/2023 6-388
    		 60601-2-21 Edition 2.1 2016-04
    Transition Inactive 07/09/2023 1-98
    		 80601-2-12 First edition 2011-04-15
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