# FDA 483 - Proven Process Medical Devices, Inc. - December 13, 2019

Source: https://www.globalkeysolutions.net/records/483/proven-process-medical-devices-inc/73890ab3-7d70-4004-8167-ad1d4d61cd80

> FDA 483 for Proven Process Medical Devices, Inc. on December 13, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Proven Process Medical Devices, Inc.
- Inspection Date: 2019-12-13
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Proven Process Medical Devices, Inc. in Mansfield, MA, a contract manufacturer, revealed significant deficiencies in their quality management system. The firm failed to establish adequate procedures for corrective and preventive actions, control of non-conforming product, and ensure the suitability and maintenance of inspection and test equipment. These observations indicate a need for comprehensive improvements in their manufacturing and quality control processes.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/proven-process-medical-devices-inc/326561d9-b03a-4d36-bc62-b432633eba53

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7