FDA Inspection 923834 — Shape Medical Systems, Inc
The FDA completed an inspection of Shape Medical Systems, Inc on April 28, 2015 in Saint Paul, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 28, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |