FDA Inspection 574528 — Nano-Ditech Corporation
The FDA completed an inspection of Nano-Ditech Corporation on April 7, 2009 in Cranbury, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 7, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cranbury, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3691 | 21 CFR 820.100(a)(4) | Verification vs validation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |