FDA Inspection 572930 — Sybaritic, Inc
The FDA completed an inspection of Sybaritic, Inc on Mar 18, 2009 in Bloomington, MN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 18, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bloomington, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |