FDA Inspection 640751 — Resource Optimization & Innovation LLC
The FDA completed an inspection of Resource Optimization & Innovation LLC on January 26, 2010 in Nashville, TN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |