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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Withdrawn ASCA Testing Laboratories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This page lists testing laboratories who have either 1) voluntarily withdrawn their ASCA Accreditation or 2) have had their ASCA Accreditation withdrawn through an FDA-initiated process.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  • Labs listed below with a status of "FDA Initiated Withdrawal" have had their ASCA Accreditation withdrawn as a result of failing to meet the requirements of the ASCA Program as detailed in Section 514(d) of the FD&C Act and the relevant ASCA guidance documents.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  • Labs listed below with a status of "Voluntarily Withdrawn" have requested that their ASCA Accreditation be withdrawn voluntarily.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: CENTRE TESTING INTERNATIONAL GROUP CO., LTD. - GUANGDONG [TL-78]
    Accreditation Status: FDA Initiated Withdrawal - Start Date: 07/27/2021 - End Date: 01/12/2026
    Accreditation Body Organization Name: A2LA
    Test Lab Primary Contact: Robin Zhang, robin.zhang@cti-cert.com, Building C, Hongwei Industrial Park, Block 70, Bao'an District, Guangdong, Peoples Republic of China Shenzhen CN 518101
     
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    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 6-385
    		 60601-2-19 Edition 2.1 2016-04
    Transition Inactive 12/17/2023 6-386
    		 60601-2-20 Edition 2.1 2016-04
    Transition Inactive 12/17/2023 6-390
    		 80601-2-35 Edition 2.1 2016-04
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