# FDA 483 - ITI Manufacturing, Inc. - June 03, 2026

Source: https://www.keypedia.com/records/483/iti-manufacturing-inc/253d80ee-4f23-4764-9a37-137e7130f338

> FDA 483 for ITI Manufacturing, Inc. on June 03, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ITI Manufacturing, Inc.
- Inspection Date: 2026-06-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: ITI Manufacturing, Inc. in Sugar Land, TX, a contract manufacturer, received a Form 483 with three observations during an FDA inspection from June 1-3, 2026. The inspection revealed significant deficiencies in the firm's quality management system. Key issues included a lack of documentation for nonconforming products, absence of written quality agreements for outsourced processes, and inadequate internal audit procedures with no audits conducted since 2003.

## Related Documents

- [483 - 2022-10-28](https://www.keypedia.com/records/483/iti-manufacturing-inc/ed5c1750-4abc-4f40-8d3d-a39c09f0363f)

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)

Company: https://www.keypedia.com/companies/iti-manufacturing-inc/7b3c5fc9-3826-4d59-a966-84fac511d0a3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab