FDA Inspection 782500 — Optima Neuroscience, Inc
The FDA completed an inspection of Optima Neuroscience, Inc on May 4, 2012 in Alachua, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 4, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alachua, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |