FDA Inspection 769507 — Omarc Llc
The FDA completed an inspection of Omarc Llc on March 1, 2012 in Norwood, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 1, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Norwood, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |