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  5. Neurotris, Inc. dba A1 Engineering - 457666 - 05/08/2020
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CLOSEOUT LETTER

Neurotris, Inc. dba A1 Engineering MARCS-CMS 457666 —

Delivery Method:
VIA Electronic Mail
Reference #:
WL# 8-16
Product:
Medical Devices

Recipient:
Recipient Name
Anthony Picciano
Recipient Title
Chief Executive Officer
Neurotris, Inc. dba A1 Engineering

30 Mauchly Suite A
Irvine, CA 92618
United States

tony@neurotris.com
Issuing Office:
Office of Medical Device and Radiological Health Operations Division 3/West

United States


 

Dear Mr. Picciano,

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL# 8-16), dated 11/19/2015. 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/

Jessica Mu

Compliance Branch Director

Office of Medical Device and Radiological Health Operations

Division 3/West

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