FDA Inspection 828183 — Electro Medical, Inc.
The FDA completed an inspection of Electro Medical, Inc. on April 19, 2013 in Tulsa, OK. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tulsa, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |