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  5. Omnisense Systems Pte Ltd - 613561 - 07/20/2023
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CLOSEOUT LETTER

Omnisense Systems Pte Ltd MARCS-CMS 613561 —

Product:
Medical Devices

Recipient:
Recipient Name
Leonard Lim
Omnisense Systems Pte Ltd

8 Penjuru Lane
609189
Singapore

enquiries@omnisense-systems.com
Issuing Office:
Center for Devices and Radiological Health

United States


Dear Leonard Lim:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #613561, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations 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 in the future.


Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Director
Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:

Andrew Southern
Invisible Health Technologies
520 West 27th St.Suite 407
New York, NY 10001
andrew@invisiblehealthtechnologies.com

Andrew Southern
Invisible Health Technologies
3250 NE 1st Ave, Suite 305
Miami, FL 33137
andrew@invisiblehealthtechnologies.com

Adam Lim
Native Instinct LLC
3206 Canal Drive,
Boynton Beach, FL 33435
adam@nativeinstinct.co

 
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