FDA Inspection 887868 — Rochester Electro Medical, Inc
The FDA completed an inspection of Rochester Electro Medical, Inc on Jul 23, 2014 in Lutz, FL. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 23, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lutz, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3159 | 21 CFR 820.184 | DHR content |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |