# FDA 483 - SURETEC INNOVATIONS LLC - March 05, 2026

Source: https://www.keypedia.com/records/483/suretec-innovations-llc/f41faa65-8b0e-4a00-96b4-688724a2dbd1

> FDA 483 for SURETEC INNOVATIONS LLC on March 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SURETEC INNOVATIONS LLC
- Inspection Date: 2026-03-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of SURETEC INNOVATIONS LLC in Gilbert, AZ, revealed critical deficiencies in its quality control unit and laboratory operations. The firm failed to ensure drug products were manufactured in accordance with current good manufacturing practices (cGMP), including issues with equipment qualification, method validation, and proper product release procedures. These findings indicate a severe lack of oversight and control over essential manufacturing and testing processes.

## Related Officers

- [Jeffrey T. Prosterman](https://www.keypedia.com/people/jeffrey-t-prosterman/1343bea3-692d-484e-b29f-c9f8f052f09c)

Company: https://www.keypedia.com/companies/suretec-innovations-llc/9c2bfe42-5b05-4533-b110-ea132d85e934

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