# FDA 483 - Aquavit Life Sciences, Inc. - December 19, 2019

Source: https://www.keypedia.com/records/483/aquavit-life-sciences-inc/19c9a3dc-7b7b-41b4-88be-43c0be8d5668

> FDA 483 for Aquavit Life Sciences, Inc. on December 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aquavit Life Sciences, Inc.
- Inspection Date: 2019-12-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Aquavit Life Sciences, Inc., an initial distributor/importer in New York, NY, was cited with eight observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including a lack of documented procedures for incoming product acceptance, complaint handling, supplier agreements, and overall quality system management. These issues indicate a systemic failure to establish and maintain adequate controls for medical devices like the AQUAGOLD Fine Touch and A.S.A.P! Micro Infusion System.

## Related Documents

- [483 - 2019-12-19](https://www.keypedia.com/records/483/aquavit-life-sciences-inc/e9b46a84-b08a-4a25-ad8c-3f2d5e329bd9)

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)
- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/aquavit-life-sciences-inc/e05c0941-1994-4089-9d63-944091686465

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961