# FDA 483 - Probed Medical Technologies, Inc. - August 11, 2022

Source: https://www.globalkeysolutions.net/records/483/probed-medical-technologies-inc/dd83da0c-fb8b-4880-bf5b-d16bb7c9cbb6

> FDA 483 for Probed Medical Technologies, Inc. on August 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Probed Medical Technologies, Inc.
- Inspection Date: 2022-08-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Probed Medical Technologies, Inc. in Abbotsford was inspected by the FDA from August 8-11, 2022. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, a lack of established complaint handling processes, and insufficient control over production processes. These issues indicate a moderate level of non-compliance with regulatory requirements for medical device manufacturing.

## Related Documents

- [WARNING_LETTER - 2011-09-15](https://www.globalkeysolutions.net/records/warning_letter/probed-medical-technologies-inc/886b72bc-7f64-4d21-8422-12af9b55e981)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/probed-medical-technologies-inc/49f7027b-5a45-4e14-bbc2-853de1017ccc

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd