FDA Inspection 974242 — ReShape Lifesciences, Inc.
The FDA completed an inspection of ReShape Lifesciences, Inc. on April 22, 2016 in Eden Prairie, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 22, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Eden Prairie, MN (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |