FDA Inspection 597980 — JAS Diagnostics, Inc./Drew Scientific, Inc.
The FDA completed an inspection of JAS Diagnostics, Inc./Drew Scientific, Inc. on Jul 14, 2009 in Miami Lakes, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 14, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3138 | 21 CFR 820.130 | Packaging |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |