# FDA 483 - Psoria Shield, Inc. - September 14, 2023

Source: https://www.globalkeysolutions.net/records/483/psoria-shield-inc/b43b80ad-903e-4685-a345-34b7a20fe192

> FDA 483 for Psoria Shield, Inc. on September 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Psoria Shield, Inc.
- Inspection Date: 2023-09-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Psoria Shield, Inc. in Utica, NY, was inspected and cited for significant deficiencies across its quality system. Observations included a lack of established procedures for equipment calibration, vendor qualification, complaint handling, and adequate corrective and preventive actions, indicating a systemic breakdown in quality management.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/psoria-shield-inc/791984f8-bfd8-43a6-a20e-bdd57c202144)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.globalkeysolutions.net/companies/psoria-shield-inc/5370e4bb-e9aa-4154-84b2-2eea319d5b97

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