> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Says Aquavit Pharmaceuticals Marketing Unapproved Devices
- URL: https://www.fdaweb.com/fda-says-aquavit-pharmaceuticals-marketing-unapproved-devices/
- Published: 2021-07-06T12:00:00.000Z
- Updated: 2026-09-14T17:04:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149648

FDA says Aquavit Pharmaceuticals is marketing the Aquagold and Advanced Skin Application Platform micro infusion system in the U.S. without marketing clearance or approval. A 6/17 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aquavit-pharmaceuticals-inc-607150-06172021?ref=fdaweb.com) says the products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The letter reviews claims made for the products on the firm’s Web sites.

Aquavit was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the steps and a timetable for completing the work.