# FDA 483 - iScreen Vision, Inc. - September 28, 2023

Source: https://www.globalkeysolutions.net/records/483/iscreen-vision-inc/2909a53e-a2e8-429f-9bd8-ff568f5339e2

> FDA 483 for iScreen Vision, Inc. on September 28, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: iScreen Vision, Inc.
- Inspection Date: 2023-09-28
- Product Type: device
- Office Name: New Orleans District Office
- Summary: iScreen Vision, Inc. in Cordova, TN, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate complaint handling, lack of supplier control, unvalidated software for record storage, and insufficient CAPA documentation. Additionally, obsolete and unapproved documents were found in use.

## Related Officers

- [Mary A. Millner](https://www.globalkeysolutions.net/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.globalkeysolutions.net/companies/iscreen-vision-inc/bbe23b01-c949-404d-a86c-44a909c7d8b4

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea