FDA Inspection 619791 — Linvatec Corp.
The FDA completed an inspection of Linvatec Corp. on Oct 14, 2009 in Largo, FL. 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
- Oct 14, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2470 | 21 CFR 820.30(c) | Design input procedures - appropriateness |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |