FDA Inspection 756393 — Insulet Corporation
The FDA completed an inspection of Insulet Corporation on Dec 19, 2011 in Billerica, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 19, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |