# FDA 483 - Prollenium Medical Technologies Inc. - November 09, 2023

Source: https://www.keypedia.com/records/483/prollenium-medical-technologies-inc/d96f5a4f-e4fb-4721-8a85-9142d9bddb36

> FDA 483 for Prollenium Medical Technologies Inc. on November 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prollenium Medical Technologies Inc.
- Inspection Date: 2023-11-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Prollenium Medical Technologies Inc. in Richmond Hill, a manufacturer of class III dermal fillers, revealed significant deficiencies in its quality system. The firm was cited for inadequate process validation, insufficient in-process product control, and flawed risk analysis for its Revanesse products. Additionally, issues were identified with the establishment and control of acceptable suppliers and contractors.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.keypedia.com/companies/prollenium-medical-technologies-inc/0fd5353b-ee08-405e-9e88-7709ddd78128

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