FDA Inspection 554189 — Puretone Ltd.
The FDA completed an inspection of Puretone Ltd. on Nov 20, 2008 in Rochester. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 20, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rochester (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3312 | 21 CFR 820.120(d) | Mixups |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |