U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Neitz Instruments Company Ltd. - 664336 - 10/02/2023
  1. Warning Letters

CLOSEOUT LETTER

Neitz Instruments Company Ltd. MARCS-CMS 664336 —

Product:
Medical Devices

Recipient:
Recipient Name
Ms. Takae Nishizawa
Recipient Title
CEO
Neitz Instruments Company Ltd.

4F Ichibancho Court 15-21
Ichibancho JP-13
Chiyoda-Ku,
102-0082
Japan

Issuing Office:
Center for Devices and Radiological Health

United States

Secondary Issuing Offices

United States


Dear Ms. Nishizawa:

The United States Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 664336, dated August 25, 2023). Based on our evaluation, it appears that you have addressed the violation(s) contained in this 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,
/S/
for Malvina B. Eydelman, M.D.
Director
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health


CC:
US AGENT:
Takahiro Haruyama
Globizz Corp.
1411 W. 190th St., #200
Gardena, California 90248, U.S.A.
Email: Register@Globizz.Net
Phone 1-310-538-3860

 
Back to Top