FDA Inspection 776738 — Curbell Medical Products, Inc.
The FDA completed an inspection of Curbell Medical Products, Inc. on Apr 9, 2012 in Orchard Park, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 9, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Orchard Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |