CLOSEOUT LETTER
Omnisense Systems Pte Ltd MARCS-CMS 613561 —
- Product:
- Medical Devices
- Recipient:
-
Recipient NameLeonard 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