FDA Inspection 643583 — Diasol, Inc
The FDA completed an inspection of Diasol, Inc on February 3, 2010 in Phoenix, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 3, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |