Aquavit Pharmaceuticals, Inc

Warning LetterOpen

Sobin Chang Chief Executive Officer Aquavit Pharmaceuticals, Inc 145 W 57th Street, 15th Floor New York , NY 10019 United States sobin.chang@aquavitpharma.comIssued Jun 17, 2021Office of Medical Device and Radiological Health Division 1 – East

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations4

Issue DateJun 17, 2021

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Aquavit Pharmaceuticals, Inc
Location: Sobin Chang Chief Executive Officer Aquavit Pharmaceuticals, Inc 145 W 57th Street, 15th Floor New York , NY 10019 United States sobin.chang@aquavitpharma.com
FEI Number: N/A
Country: United States
Issue Date: June 17, 2021
Issuing Office: Office of Medical Device and Radiological Health Division 1 – East
Product Type: Medical Devices
Status: Open

Summary

Aquavit Pharmaceuticals was found marketing two medical devices—the AQUAGOLD® fine touch microchannel microinjector and the A.S.A.P! Micro Infusion System—without required FDA premarket approval (PMA) or investigational device exemption (IDE) authorization. The devices were determined to be adulterated under federal law because the company lacked approved applications for commercial distribution, and were also misbranded because the firm failed to submit the required 510(k) notification of intent to introduce the devices into commerce. Both devices were marketed through the company's websites for delivering therapeutic solutions into skin for various aesthetic and medical concerns.

Aquavit Pharmaceuticals, Inc FDA Warning Letter, June 17, 2021