# FDA 483 - The Skin Atelier, Inc. - July 26, 2024

Source: https://www.globalkeysolutions.net/records/483/the-skin-atelier-inc/bb79e626-50dc-4977-98ad-e4bbd6d98fac

> FDA 483 for The Skin Atelier, Inc. on July 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Skin Atelier, Inc.
- Inspection Date: 2024-07-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The Skin Atelier, Inc., an OTC drug manufacturer in Goshen, NY, was cited for significant deficiencies in its quality control unit, particularly regarding oversight of contract operations and the absence of critical written procedures. The inspection revealed a lack of proper supplier qualification, inadequate stability data to support product expiration dates, and failures in managing and inspecting reserve samples. These issues indicate a systemic breakdown in quality management, with some observations being repeats from previous inspections.

## Related Documents

- [483 - 2019-04-04](https://www.globalkeysolutions.net/records/483/the-skin-atelier-inc/6522137a-c724-41d0-ba1a-a67ab5e9dd46)

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

Company: https://www.globalkeysolutions.net/companies/the-skin-atelier-inc/f33022c5-32de-4553-abd7-127525044a25

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