FDA Inspection
Prollenium Medical Technologies Inc.Prollenium Medical Technologies Inc. – FDA Inspection, Jul 13, 2017
Record Details
This FDA Inspection record concerns Prollenium Medical Technologies Inc., with an inspection on July 13, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- July 13, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 806107e4-817c-4da8-ae29-684098f77c70
Inspection Facts
- Inspection number
- 1018068
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
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Other FDA inspections of Prollenium Medical Technologies Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2024 | Not classified | Office of Inspections and Investigations | Project Evaluation: Devices |
| November 1, 2018 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 20, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Prollenium Medical Technologies Inc.
- FDA Inspection 1230525 - 2024-04-25
- FDA Inspection 1070919 - 2018-11-01
- FDA Inspection 1011040 - 2017-04-20
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