FDA Inspection 571631 — Linvatec Corp.
The FDA completed an inspection of Linvatec Corp. on Mar 26, 2009 in Largo, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |