# FDA 483 - Alpha ProTech Inc. - July 22, 2021

Source: https://www.globalkeysolutions.net/records/483/alpha-protech-inc/2832bdd8-c501-4f85-895a-c458f7d71faa

> FDA 483 for Alpha ProTech Inc. on July 22, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alpha ProTech Inc.
- Inspection Date: 2021-07-22
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Alpha ProTech Incorporated, a medical device manufacturer in Salt Lake City, UT, revealed two significant observations. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding the verification of CAPA effectiveness. Additionally, complaint files were not adequately maintained, with evaluations for reportability lacking proper documentation.

## Related Documents

- [483 - 2023-05-11](https://www.globalkeysolutions.net/records/483/alpha-protech-inc/6806c98a-f808-4e95-abad-e93cbcbcf6ea)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/alpha-protech-inc/afa89840-6bdc-4b2e-80d1-e80f7fb8dc74

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