Company
United StatesProllenium Medical Technologies Inc. – FDA Inspections
Inspection records and compliance data for Prollenium Medical Technologies Inc.. 1 FDA inspection on record, 1 Form 483, last inspected November 09, 2023.
Company Profile
This profile covers Prollenium Medical Technologies Inc..
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected November 9, 2023.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documentation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2023 | VAI | Medical Devices & Rad Health | 1222365 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Prollenium Medical Technologies Inc.
FEI Number
3019585045
ID: 0fd5353b-ee08-405e-9e88-7709ddd78128