FDA Inspection 815766 — CooperSurgical, Inc.
The FDA completed an inspection of CooperSurgical, Inc. on Jan 16, 2013 in Trumbull, CT. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 16, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Trumbull, CT (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |