FDA Inspection 709696 — 3CPM Company., INC.- EndoSure, Inc.
The FDA completed an inspection of 3CPM Company., INC.- EndoSure, Inc. on Feb 25, 2011 in Sparks Glenco, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 25, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sparks Glenco, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3696 | 21 CFR 820.100(b) | Documentation |