FDA Inspection 1211003 — Insulet Corporation
The FDA completed an inspection of Insulet Corporation on Jul 28, 2023 in Acton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 28, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Acton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |