FDA Inspection
ReShape Lifesciences, Inc.ReShape Lifesciences, Inc. – FDA Inspection, Nov 25, 2013
Record Details
This FDA Inspection record concerns ReShape Lifesciences, Inc., with an inspection on November 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ReShape Lifesciences, Inc.
- Inspection Date
- November 25, 2013
- Product Type
- Devices
View Company Profile
ID · 990239b7-09ea-419b-9b89-911122298ba3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 856112
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
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Other FDA inspections of ReShape Lifesciences, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 |
| June 17, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ReShape Lifesciences, Inc.
- FDA Inspection 1091756 - 2019-05-22
- FDA Inspection 1036574 - 2017-12-18
- FDA Inspection 974242 - 2016-04-22
- FDA Inspection 838101 - 2013-06-17
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