FDA Inspection 981273 — ROMD, LLC
The FDA completed an inspection of ROMD, LLC on August 2, 2016 in Rochester Hills, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 2, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |