# FDA 483 - Amperor Inc. - October 29, 2019

Source: https://www.globalkeysolutions.net/records/483/amperor-inc/a3d3b620-4c3f-4f62-8e4c-7c046eda8880

> FDA 483 for Amperor Inc. on October 29, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amperor Inc.
- Inspection Date: 2019-10-29
- Product Type: device
- Office Name: Dallas District Office
- Summary: Promisector Inc., an initial importer in Houston, TX, was cited with five observations during an FDA inspection from October 22-29, 2019. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning complaint handling, medical device reporting, control of nonconforming product, corrective and preventive actions, and finished device distribution. These issues indicate a lack of established and implemented procedures for critical quality processes.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/amperor-inc/a9b7f013-013a-4b96-9175-47da7587c156

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9