FDA Inspection 629330 — 3CPM Company., INC.- EndoSure, Inc.
The FDA completed an inspection of 3CPM Company., INC.- EndoSure, Inc. on November 6, 2009 in Sparks Glenco, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 6, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sparks Glenco, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3333 | 21 CFR 820.184(f) | Device identification, control numbers |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |