FDA Inspection 663988 — Diagnostic Automation/Cortez Diagnostics Inc
The FDA completed an inspection of Diagnostic Automation/Cortez Diagnostics Inc on May 28, 2010 in Woodland Hills, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 28, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Woodland Hills, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |