FDA Inspection 611027 — Jensen Industries, Inc.
The FDA completed an inspection of Jensen Industries, Inc. on Sep 3, 2009 in North Haven, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- North Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3691 | 21 CFR 820.100(a)(4) | Verification vs validation |
| 3693 | 21 CFR 820.100(a)(5) | Implementing changes |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |