# FDA 483 - Prugen Inc. Pharmaceuticals - August 13, 2018

Source: https://www.globalkeysolutions.net/records/483/prugen-inc-pharmaceuticals/085fbe7f-b17a-47b8-8871-47c19dc03a04

> FDA 483 for Prugen Inc. Pharmaceuticals on August 13, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prugen Inc. Pharmaceuticals
- Inspection Date: 2018-08-13
- Product Type: device
- Office Name: Denver District Office
- Summary: Prugen Inc. Pharmaceuticals in Scottsdale, AZ, was inspected by the FDA from August 9-13, 2018. The inspection identified a significant deficiency in the firm's investigation records for Medical Device Report (MDR) reportable complaints. These records lacked critical information regarding device specifications, usage, relationship to adverse events, investigation details, and corrective actions.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maksim-a-levenchuk/d77c93d7-d86e-4df8-b803-abae068a4dd2)

Company: https://www.globalkeysolutions.net/companies/prugen-inc-pharmaceuticals/05bfd4f7-e6fd-44b5-832f-a706220dd821

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face