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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Withdrawn ASCA Testing Laboratories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This page lists testing laboratories who have either 1) voluntarily withdrawn their ASCA Accreditation or 2) have had their ASCA Accreditation withdrawn through an FDA-initiated process.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  • Labs listed below with a status of "FDA Initiated Withdrawal" have had their ASCA Accreditation withdrawn as a result of failing to meet the requirements of the ASCA Program as detailed in Section 514(d) of the FD&C Act and the relevant ASCA guidance documents.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  • Labs listed below with a status of "Voluntarily Withdrawn" have requested that their ASCA Accreditation be withdrawn voluntarily.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: Intertek Japan K.K. Matsuda Laboratory [TL-101]
    Accreditation Status: Voluntarily Withdrawn - Start Date: 02/10/2022 - End Date: 10/07/2024
    Accreditation Body Organization Name: National Voluntary Laboratory Accreditation Program (NVLAP)
    Test Lab Primary Contact: Yaqing Liu, Yaqing.liu@intertek.com, 1283 Yadoriki, Matsuda Ashigarakami-gun Kanagawa JP 258-0001
     
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    Transition Inactive 12/17/2023 19-8
    		 60601-1-2 Edition 4.0 2014-02
    Excluding 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
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