Company
United StatesReShape Lifesciences, Inc., Eden Prairie, MN – FDA Inspections
Inspection records and compliance data for ReShape Lifesciences, Inc. in Eden Prairie, Minnesota. 5 FDA inspections on record, 2 Form 483s, last inspected May 22, 2019.
Company Profile
This profile covers ReShape Lifesciences, Inc. based in Eden Prairie, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected June 17, 2013. Last inspected May 22, 2019.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1091756 |
| December 18, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1036574 |
| April 22, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 974242 |
| November 25, 2013 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 856112 |
| June 17, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 838101 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ReShape Lifesciences, Inc.
FEI Number
3005025697
Address
7625 Golden Triangle Dr Ste G, Eden Prairie, Minnesota 55344-3700, United States
Country
United States
ID: 740415bf-ee64-46b0-91ff-3ff435f3769d