# FDA 483 - ITI Manufacturing, Inc. - October 28, 2022

Source: https://www.keypedia.com/records/483/iti-manufacturing-inc/ed5c1750-4abc-4f40-8d3d-a39c09f0363f

> FDA 483 for ITI Manufacturing, Inc. on October 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ITI Manufacturing, Inc.
- Inspection Date: 2022-10-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: ITI Manufacturing, Inc., an initial importer and contract manufacturer in Sugar Land, TX, was inspected by the FDA from October 18-28, 2022. The inspection revealed significant deficiencies in the firm's quality management system, specifically regarding inadequate procedures for corrective and preventive actions and product handling. These issues indicate a lack of established and complete procedures essential for device quality.

## Related Officers

- [Ellen J. Tave](https://www.keypedia.com/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

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