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  5. ELITech Group B.V. - 534429 - 06/18/2020
  1. Warning Letters

CLOSEOUT LETTER

ELITech Group B.V. MARCS-CMS 534429 —

Product:
Medical Devices
Recipient:
Recipient Name
Adriaan P. Intveld
Recipient Title
Manager Quality Assurance & Regulatory Affairs
ELITech Group B.V.

Van Rensselaerweg 4
Gelderland
6956 AV Spankeren
Netherlands

Issuing Office:
"OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality"

United States

Dear Adriaan P. Intveld:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 534429, dated September 20, 2017). Based on our evaluation, it appears that your firm has addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Deputy Director for Patient Safety and Product
Quality
Office of In Vitro Diagnostics and Radiological
Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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