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Hoya Corporation - Pentax Life Division MARCS-CMS 546991 —

Medical Devices

Recipient Name
Ojas A. Buch
Recipient Title
Hoya Corporation - Pentax Life Division
PENTAX Medical - Americas

3 Paragon Drive
Montvale, NJ 07645
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Ojas A. Buch:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546991, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter.

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,
Courtney H. Lias, Ph.D.
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Center for Devices and Radiological Health

William Goeller
Vice President, Quality Assurance and Regulatory Affairs
Pentax Medical- A Division of Pentax of America, Inc.
3 Paragon Drive
Montvale, New Jersey 07645

Mr. Hiroshi Suzuki
President and CEO
Hoya Corporation (PENTAX Life Care Division)
Showanomori Technology Center
1-1-110 Tsutsujigaoka, Akishima-shi
Tokyo 196-0012

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