Company
United StatesShape Medical Systems, Inc, Saint Paul, MN – FDA Inspections
Inspection records and compliance data for Shape Medical Systems, Inc in Saint Paul, Minnesota. 4 FDA inspections on record, 1 Form 483, last inspected March 02, 2023.
Company Profile
This profile covers Shape Medical Systems, Inc based in Saint Paul, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 6, 2011. Last inspected March 2, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 2, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1200080 |
| July 22, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1098757 |
| April 28, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 923834 |
| September 6, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 743986 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Shape Medical Systems, Inc
FEI Number
3008072932
Address
5000 Township Pkwy, Saint Paul, Minnesota 55110, United States
Country
United States
ID: d2fd11a1-6767-474d-9763-6cdd6f232a13