FDA Inspection 573802 — Apheresis Technologies, Inc.
The FDA completed an inspection of Apheresis Technologies, Inc. on April 1, 2009 in Palm Harbor, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 1, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Palm Harbor, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |