FDA Inspection 633739 — Covidien LP
The FDA completed an inspection of Covidien LP on Dec 10, 2009 in Mansfield, 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mansfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |