FDA Inspection
ReShape Lifesciences, Inc.ReShape Lifesciences, Inc. – FDA Inspection, May 22, 2019
Record Details
This FDA Inspection record concerns ReShape Lifesciences, Inc., with an inspection on May 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e4e54b6b-de8f-410c-9f4c-67b3c01d41f9
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1091756
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ReShape Lifesciences, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 22, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 25, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 17, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ReShape Lifesciences, Inc.
- FDA Inspection 1036574 - 2017-12-18
- FDA Inspection 974242 - 2016-04-22
- FDA Inspection 856112 - 2013-11-25
- FDA Inspection 838101 - 2013-06-17
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