FDA Inspection
ReShape Lifesciences, Inc.ReShape Lifesciences, Inc. – FDA Inspection, Dec 18, 2017
Record Details
This FDA Inspection record concerns ReShape Lifesciences, Inc., with an inspection on December 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · feb5d6d2-62f7-407c-accc-83f1f06b20bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1036574
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
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 |
| 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 1091756 - 2019-05-22
- FDA Inspection 974242 - 2016-04-22
- FDA Inspection 856112 - 2013-11-25
- FDA Inspection 838101 - 2013-06-17
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