# FDA 483 - Promedtek, Inc. - March 22, 2023

Source: https://www.globalkeysolutions.net/records/483/promedtek-inc/9107871d-2fcf-4af0-9e98-f78f256c6e09

> FDA 483 for Promedtek, Inc. on March 22, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Promedtek, Inc.
- Inspection Date: 2023-03-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Promedtek, Inc. in Scottsdale, AZ, a specification developer, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in establishing procedures for finished device acceptance, specifically regarding output specification testing. Additionally, the firm failed to include required details in its complaint investigation records for multiple confirmed and applicator-related issues.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/promedtek-inc/1c53d2ae-12c9-4971-becf-37e1f801ed6e

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6